BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    USS-HOOK+SCRHOLDER W/HEX-SOCKET Ø4

    MDR report key: 3160566 · Received June 10, 2013

    Report

    Report Number
    2520274-2013-03273
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    June 13, 2012
    Report Date
    June 18, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    STICK THREAD BROKEN INTO THE SCREW DURING SURGERY, THE SCREW HAS BEEN REMOVED FROM THE PATIENT. THIS IS 1 OF 1 REPORT FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261284 USS-HOOK+SCRHOLDER W/HEX-SOCKET Ø4 LXH SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR