BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILHOUETTE PEDICLE SCREW SYSTEM

    MDR report key: 1739329 · Received June 25, 2010

    Report

    Report Number
    2184052-2010-00020
    Event Type
    Injury
    Date Received
    June 25, 2010
    Date of Event
    May 17, 2010
    Report Date
    May 27, 2010
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEWED DEVICE HISTORY RECORDS. DEVICE WAS MANUFACTURED TO OTHER APPLICABLE SPECIFICATIONS.

    Description of Event or Problem · 1

    FOUR YEARS AFTER ORIGINAL SURGERY, A REVISION SURGERY WAS PERFORMED TO REMOVE A BROKEN PEDICLE SCREW. NO PATIENT INJURY WAS REPORTED. SURGEON REINSTRUMENTED WITH A DIFFERENT PEDICLE SCREW SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILHOUETTE PEDICLE SCREW SYSTEM 6.5X50MM PEDICLE SCREW NKB ZIMMER SPINE, INC. 7220-6550-00 P041246

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other