BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDER FOR SYNFRAME BONE LEVERS

    MDR report key: 3030019 · Received April 2, 2013

    Report

    Report Number
    8030965-2013-01305
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. 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

    DURING AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) PROCEDURE UTILIZING A SYNFRAME IMPLANT KIT, ONE OF THE FOUR HOLDER FOR SYNFRAME BONE LEVERS FROM THE KIT THAT ATTACHES TO THE LEVER BROKE WITH NO FRAGMENTS REPORTED. THE SURGEON USED A DIFFERENT HANDLE AND COMPLETED THE PROCEDURE WITH NO FURTHER INCIDENT. THERE WAS NO DELAY OR ADVERSE EVENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134622 HOLDER FOR SYNFRAME BONE LEVERS LXH SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1