BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOLT Ø4.9 SELF-TAP L34 SST

    MDR report key: 2822512 · Received November 7, 2012

    Report

    Report Number
    8030965-2012-01203
    Event Type
    Injury
    Date Received
    November 7, 2012
    Report Date
    October 30, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED. PLACEHOLDER.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED: PATIENT WAS IMPLANTED ON AN UNKNOWN DATE WITH PFNA NAIL. IT WAS DISCOVERED ON AN UNKNOWN DATE THE NAIL WAS BROKEN. PATIENT WAS RETURNED TO THE OR ON AN UNKNOWN DATE AND THE HARDWARE WAS REMOVED. IT IS NOT KNOWN IF THE PATIENT WAS IMPLANTED WITH ANY NEW HARDWARE. NO FURTHER INFORMATION IS AVAILABLE. AFTER FURTHER REVIEW OF THE FILE, THE BLADE AND BOLT WERE ADDED TO THIS COMPLAINT BASED ON PATIENT HAVING PSEUDOARTHROSIS. THIS IS 3 OF 3 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOLT Ø4.9 SELF-TAP L34 SST BOLT Ø4.9 SELF-TAP KTT SYNTHES GMBH 2736980

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NAIL, BLADE, SCREW