BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL-HOLDER F/SYNFIX-LR

    MDR report key: 3061520 · Received April 16, 2013

    Report

    Report Number
    2520274-2013-01982
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 19, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. ADDITIONAL INFORMATION. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON (B)(6) 2013 THE THREADED TIP OF THE IMPLANT HOLDER FOR SYNFIX BROKE OFF. THE FRAGMENT FROM THE IMPLANT HOLDER REMAINED IN THE PATIENT, AS IT WAS DEEMED UNREMOVABLE. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORT OF ADDITIONAL INCIDENTS. THIS REPORT IS FOR A IMPLANT HOLDER F/SYNFIX-LR. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163659 IMPL-HOLDER F/SYNFIX-LR LXH SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1