Events

Rappel de Fortex Pedicle Screw System

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 XTANT MEDICAL INC.

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
    76842
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1884-2017
  • Date de mise en oeuvre de l'événement
    2017-04-12
  • Date de publication de l'événement
    2017-04-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-08-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154382
  • 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
    Orthosis, spondylolisthesis spinal fixation - Product Code MNH
  • Cause
    The material type on the label may incorrectly state ti6al-4v eli. the rods are composed of cobalt chromium.
  • Action
    XTANT sent an Urgent Medical Device Removal letter dated 4/12/2017 to customers with a Return Response Acknowledgement and Receipt form. The letter identified the affected product, problem and actions to be taken. For questions call 406-570-7028.

Device

Fortex Pedicle Screw System
  • Modèle / numéro de série
    Part number X077-0420, lot number 041218
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution - US Nationwide in the states of: AZ, CA, CT, GA, LA, NV, OH, TX and in the country of Mexico.
  • Description du dispositif
    5.5mm Diameter x 500mm CoCr Straight Rod, Model number X077-0420. The product is packaged in plastic bags with one piece per bag. || Product Usage: || The 5.5mm dia. X 500 mm CoCr Straight Rod is an accessory to the Fortex Pedicle Screw System. It is a straight rod connected between two or more pedicle screws to create a pedicle screw construct. Indications for Use: The Fortex Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
  • Manufacturer
    XTANT MEDICAL INC

Manufacturer

XTANT MEDICAL INC
  • Adresse du fabricant
    XTANT MEDICAL INC, 664 Cruiser Ln, Belgrade MT 59714-9719
  • Société-mère du fabricant (2017)
    Xtant Medical Holdings, Inc.
  • Source
    USFDA