BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SPREADER 7MM BEAK WIDTH

    MDR report key: 3173603 · Received June 17, 2013

    Report

    Report Number
    2520274-2013-03454
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND A LOT NUMBER WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS.DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED.(B)(4).

    Description of Event or Problem · 1

    DURING A PROCEDURE, THE LAMINOUS SPREADER TIP BROKE AND REMAINED IN THE PATIENT AFTER WOUND CLOSURE. NO DELAY WAS ADDED TO THE PROCEDURE. THIS IS REPORT 1 OF 1 FOR COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273095 BONE SPREADER 7MM BEAK WIDTH MISC ORTHO SURGICAL INSTR LXH SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR