Events

Rappel de Device Recall Spine & Trauma 3D 2.0

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Brainlab AG.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    67569
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1469-2014
  • Date de mise en oeuvre de l'événement
    2013-11-18
  • Date de publication de l'événement
    2014-04-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-07-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125729
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Neurological stereotaxic Instrument - Product Code HAW
  • Cause
    The "fluoro match registration" function of the navigation software spine & trauma 3d 2.0 allows the user to intraoperatively match e.G., ct data sets to the current patient anatomy visible on fluoroscopic images, used by the navigation software during spinal surgeries to display the position and orientation of instruments. for this registration function in combination with a digitally integrated.
  • Action
    Brainlab sent a FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letter dated November 18, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter included instructions for the modification of C-arm configurations: 1) If possible, Use analog image transfer between C-arm and Brainlab Navigation System and to consult with the local Brainlab Customer Support Representative for this modification, and 2) If possible, adjust the image size of the C-arm to 8 bit and to follow the instructions provided with the C-arm and if required to consult the C-arm manufacturer. For measures when performing a Fluoro match registration, the following instructions are provided to reduce the probability that the algorithm results in an inaccurate match: 1) perform the preoperative CT scans according to the descriptions in the Brainlab scan protocol, 2) set the threshold so that a smooth bone surface is displayed and the quality of the chosen bone threshold influences the accuracy of the match result (refer to section "Bone Threshold" in the Software User Guide"), 3) use the Radiolucent Spine Reference Clamp instead of the Spine Reference X-Clamp, 4) make sure that no additional objects (e.g. wires, retractors, instruments, etc.) are within the view of the C-arm. Additional reminders in the letter include: 1) always verify registration accuracy by holding the pointer or instrument tip to at least three anatomical landmarks and verifying their position in the software, 2) verify that the registration is at the correct level on the patient and data set, and 3) accuracy must be checked on the treated bone surface. Brainlab will provide a software update with the issue solved to affected customers tentatively by January 2014. Customers with questions can contact the Customer Hotline at 800-597-5911 or via e-mail at us.support@brainlab.com.

Device

Device Recall Spine & Trauma 3D 2.0
  • Modèle / numéro de série
    Catalog Number: 22264; Serial Numbers: 000000000038012001 , 000000000060912001 , 000000000189912001 , 000000000224912001 , 000000000235512001 , 000000000282912001 , 000000000313612001 , 000000000319412001 , 000000000351112001 , 000000000356912001 , 000000000367212001 , 000000000433712001 , 000000000482012001 , 000000000502812001 , 000000000645612001 , 000000000731112001 , 000000000837312001 , 000000000898312001 , 000000000956812001 , 000000000998412001 , 000000001012812001 , 000000001105412001 , 000000001231812001 , 000000001353512001 , 000000001355412001 , 000000001433712001 , 000000001473712001 , 000000001493512001 , 000000001493712001 , 000000001566212001 , 000000001579112001 , 000000001635112001 , 000000001758212001 , 000000001770212001 , 000000001789312001 , 000000001868312001 , 000000001895412001 , 000000001909912001 , 000000002036112001 , 000000002309812001 , 000000002439112001 , 000000002468312001 , 000000002503012001 , 000000002573012001 , 000000002682913001 , 000000003000913001 , 000000003053313001 , 000000003066813001 , 000000003071613001 , 000000003087613001 , 000000003109513001 , 000000003109613001 , 000000003230113001 , 000000003246713001 , 000000003304113001 , 000000003331913001 , 000000003379313001 , 000000003453413001 , 000000003453513001 , 000000003622213001 , 000000003671813001 , 000000003744413001 , 000000003758413001 , 000000003819613001 , 000000003824913001 , 000000003866013001 , 000000003937813001 , 000000004094013001 , 000000004147413001 , 000000004356413001 , 000000004404013001 , 000000004489313001 , 000000004489413001 , 000000004505313001 , 000000004821913001 , 000000004882013001 , 000000004905013001 , 000000005396313001 , 000000005407413001 , 000000005505113001 , 000000005506013001 , 000000005531913001 , 000000005552313001 , 000000005578713001 , 000000005659713001 , 000000005702513001 , 000000005788213001 , 000000005817113001 , 000000005904513001 , 000000005904613001 , 000000005904713001 , 000000005904813001 , 000000005946713001 , 000000006046413001 , 000000006046513001 , 000000006096913001 , 000000006136313001 , 000000006233113001 , 000000006296713001 , 000000006426913001 , 000000006427213001 , 000000006621613001 , 000000006621613002 , 000000006656613001 , 000000006792613001 , 000000006833413001 , 000000006839413001 , 000000006998813001 , 000000007000113001 , 000000007122113001 , 000000007172913001 , 000000007405013001 , 000000007588513001 , 000000007637114001 , 000000007679714001 , 000000007698714001 , 000000007784614001 , 000000007859414001 , 000000007906314001 , 000000008020214001 , 000000008031314001 , 000000008184514001 , 000000008193214001 , 000000008199814001 , 000000008214014001 , 000000008259514001 , 000000008383314001 , 000000009718312001 , 000000009720812001 , 000000009781112001 , 000000009802512001 , 000000009901612001 , 000000009983912001
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Distribution including the states of AZ, CA,GA, IL, IN, LA, MA, MI, NY, NC, OH, PA, TN, TX and WI and the countries of Australia, Austria, Belgium, Brazil, Chile, Czech Republic, France, Germany, Italy, Japan, Malaysia, Netherlands, Norway, Philippines, Poland, Russian Federation, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey and United Kingdom.
  • Description du dispositif
    Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative image-guided localization system to enable minimally invasive surgery. Catalog Number: 22264
  • Manufacturer
    Brainlab AG

Manufacturer

Brainlab AG
  • Adresse du fabricant
    Brainlab AG, Kapellenstrasse 12, Feldkirchen Germany
  • Société-mère du fabricant (2017)
    Brainlab AG
  • Source
    USFDA