BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRG, OCC. SCREW,4.5X10MM

    MDR report key: 5918388 · Received August 31, 2016

    Report

    Report Number
    0002184052-2016-00191
    Event Type
    Injury
    Date Received
    August 31, 2016
    Date of Event
    August 2, 2016
    Report Date
    August 3, 2016
    Manufacturer
    ZIMMER SPINE
    Product Code
    KWP
    PMA / PMN Number
    PK133556
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE SALES ASSOCIATE REPORTED SCREWS BACKED OUT AFTER PATIENT FELL. THE PATIENT FELL POST-SURGERY AND THE OCCIPITAL SCREWS BACKED OUT OF OCCIPITAL PLATE. THIS WAS THE VIRAGE SYSTEM. THE PATIENT HAD OCCIPITAL FUSION IN MAY. NEW SCREWS WERE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568566 VIRG, OCC. SCREW,4.5X10MM SCREW KWP ZIMMER SPINE N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R