Events

Rappel de Medtronic TSRH 3DX Implant Set

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 Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK.

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
    50185
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1014-2009
  • Date de mise en oeuvre de l'événement
    2008-10-31
  • Date de publication de l'événement
    2009-03-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-11-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74914
  • 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, spinal pedicle fixation, for degenerative disc disease - Product Code MNI
  • Cause
    The thickness of the connector may be under specification, which could cause the implant to break during surgery or after implantation.
  • Action
    Hospital risk managers and implanting physicians were notified separately by letters dated 1/9/09. The letters advised of the recall, reported that a firm representative would visit the facility to pick up the recalled products. Physicians were instructed to closely monitor their patients during postoperative visits, to notify any other physician who may be monitoring the patient in lieu of the implanting physician, and to advise their patients to contact them immediately if they have any sudden and significant symptoms (increased discomfort, sudden change in their clinical symptoms, or new symptoms such as leg pain, back pain or irritation of local tissue). Customers were also instructed to complete and return the attached questionnaire to Medtronic SOFAMOR DANEK via mail (enclosed self-addressed stamped envelope) or fax at 901-399-2047. Direct questions to your Medtronic SOFAMOR DANEK Sales Representative or the firm's Global Quality Department at 800-876-3133, extension 6333.

Device

Medtronic TSRH 3DX Implant Set
  • Modèle / numéro de série
    All lots.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution including states of Arizona, Connecticut, Georgia, Indiana, Minnesota, New Jersey, New York, South Carolina, Texas and Washington.
  • Description du dispositif
    Medtronic TSRH 3DX Implant Set; SPS002058. Sets are unlabeled, but contain individually labeled 3Dx Splined Connectors in sizes small, medium and large. || The device is intended for orthosis, spinal pedicle fixation for degenerative disc disease. The product is used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients; posterior non-cervical, non-pedicle screw fixation or for anterior use for certain conditions.
  • Manufacturer
    Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK

Manufacturer

Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK
  • Adresse du fabricant
    Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK, 2500 Silveus Crossing, Warsaw IN 46582-8598
  • Source
    USFDA