BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERVSPINE-EXP-HEADSCR Ø4 SELF-TAP L14 TI

    MDR report key: 2912357 · Received January 11, 2013

    Report

    Report Number
    8030965-2013-00125
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 15, 2012
    Report Date
    December 14, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. IMPLANT DATE REPORTED AS (B)(6) 2011. DEVICE IS NOT DISTRIBUTED IN THE US, BUT A SIMILAR DEVICE IS MARKETED IN THE US.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A SPONDYLODESIS OF C5 TO C7 THE PATIENT WAS IMPLANTED WITH HARDWARE. DURING AN ANNUAL REVISION ON (B)(6) 2012 X-RAYS REVEALED TWO OF SIX BROKEN LOCKING SCREWS, AND THE CERVICAL SPINE EXPANSION HEAD SCREWS TO BE BROKEN OR DAMAGED. REVISION SURGERY TOOK PLACE ON (B)(6) 2012. THIS IS 14 OF 14 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19116 CERVSPINE-EXP-HEADSCR Ø4 SELF-TAP L14 TI CERVSPINE-EXP-HEADSCR Ø4 SELF-TAP L14 TI KWQ SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention PLATES, SCREWS