Events

Rappel de Signature Patient Specific Surgical Guides

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 Materialise N.V..

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
    72425
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0162-2016
  • Date de publication de l'événement
    2015-10-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-02-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141084
  • 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
    Patient specific manual orthopedic stereotaxic system - Product Code OSF
  • Cause
    Potential inaccuracies in the alignment of the guides. surgery was inaccurately planned because the patient image data was incorrectly processed.
  • Action
    On September 16, 2015 Materialise NV identified four cases where not all available image sets were used to design the case. On September 18, 2015, prior to the surgery dates Materialise informed (phone call) the Signature Services Manager of Zimmer Biomet that inaccuracies in the alignment of the knee might be observed with the use of the guides due to this issue. Biomet was asked to segregate the packages for these four cases and to return them to the Materialise US office. On September 23, 2015 this was followed up by e-mail notification letter with response forms. Biomet was requested to contact Materialise customer service to return these four cases and arrange a replacement set of patient specific surgical guides Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time. E-mail : ortho-quality@materialise. be Customer Service Materialise USA LLC 44650 Helm Court Plymouth, Michigan 48170 734-259-7033

Device

Signature Patient Specific Surgical Guides
  • Modèle / numéro de série
    42422461: Signature SIG CT/TI(A Guides 04-05 Slidex Distal-MP/Premier Tibial & 42422551 : Signature TKA GDE/MDL SET 03-05 MP/Premier Distal- MP/Premier Tibial  42422461 139540 2016-02-17  42-422551 1 391 51 2016-01-14  42422551 1 38805 2016-02-03  42-422551 140787 2016-03-03
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed in MI, ID, TX, and in France.
  • Description du dispositif
    Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part of the Signature Personalized Patient Care System.
  • Manufacturer
    Materialise N.V.

Manufacturer

Materialise N.V.
  • Adresse du fabricant
    Materialise N.V., 15 Technologielaan, Heverlee Belgium
  • Société-mère du fabricant (2017)
    Materialise Nv
  • Source
    USFDA