Events

Rappel de Device Recall MAYFIELD Composite Series Skull Clamp

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 Integra LifeSciences Corp..

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
    66449
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0210-2014
  • Date de mise en oeuvre de l'événement
    2013-08-29
  • Date de publication de l'événement
    2013-11-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-01-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122417
  • 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
    Holder, head, neurosurgical (skull clamp) - Product Code HBL
  • Cause
    An investigation of an adverse trend of complaints for the skull clamp index locking knob not easily unlocking or disengaging and malfunctions of the 80 lbs. torque knob was initiated. none of the complaints resulted in a report of patient injury, adverse health consequence, or a delay / prolongation of the surgical procedure.
  • Action
    Integra sent an Urgent: Voluntary Medical Device Recall Notification dated August 29, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Your local Integra NeuroSpecialist will set up a time with you to discuss replacement options but in the interim, Integra is asking that you do the following: 1. Review your inventory and determine if you have any MAYFIELD¿ Composite Series Skull Clamps (A3059). If so, stop using them immediately and remove them from service to prevent any inadvertent use of the Composite Series Skull Clamp. Either while the Integra NeuroSpecialist is on-site or independently; 2. Complete the attached form. If you do not have affected product, check the box: I do not have Composite Series Skull Clamps. 3. If you do have affected product, check the box: I do have Composite Series Skull Clamps. Record the total quantity and Serial No.(s) of all Skull Clamps in your inventory. The Serial No. is located on the clamp upright comprised of two letters (SS) followed by six numerals. 4. Complete the other information and return by email or fax as indicated on the form, or give it to the Integra NeuroSpecialist who will return it for you. For assistance returning and exchanging these products or any other questions that you may have, please contact Integra Customer Service at 1-855-532-1723. We sincerely apologize for any inconvenience this may have caused and thank you for your cooperation.

Device

Device Recall MAYFIELD Composite Series Skull Clamp
  • Modèle / numéro de série
    The following serial numbers are affected by this recall: SS120076, SS120082, SS120083, SS120084, SS120088, SS120089, SS120090, SS120092, SS120093, SS120094, SS120095, SS120111, SS120112, SS120113, SS120114, SS120115, SS120116, SS120117, SS120118, SS120119, SS120120, SS120121, SS120122, SS120123, SS120124, SS120125, SS120126, SS120127, SS120128, SS120130, SS120131, SS120133, SS120134, SS120135, SS120171, SS120252, SS120256, SS120257
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution including the states of AL, AR, CA, CT, FL, GA, IA, IL, MS, NY, OH, SC, TN, and TX.
  • Description du dispositif
    Composite Series Skull Clamp, one clamp per tote. || The MAYFIELD¿ Skull Clamp (A3059) is a cranial stabilization device, designed to provide rigid skeletal fixation. The Skull Clamp is placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid skeletal fixation is necessary
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.