BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.5MM SETSCREW EXTRACTOR

    MDR report key: 2143581 · Received June 3, 2011

    Report

    Report Number
    1719045-2011-00275
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 24, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. H4: UNABLE TO PROVIDE THE DATE OF MANUFACTURE AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. W/O A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE REQUESTED.

    Description of Event or Problem · 1

    DURING A LUMBAR FUSION L3-4 SCHEDULED REMOVAL PROCEDURE SURGEON USED THE SYNTHES SET SCREW EXTRACTOR ON A NON-SYNTHES PRODUCT. THE EXTRACTOR BROKE OFF FLUSH IN THE HEAD OF THE SET SCREW. SURGEON DID NOT REMOVE THE PIECE AND DID NOT REMOVE THE NON-SYNTHES HARDWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.5MM SETSCREW EXTRACTOR SETSCREW EXTRACTOR LXH SYNTHES MONUMENT NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR SCREW