BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONICAL EXTRACTION SCREW

    MDR report key: 2150211 · Received June 10, 2011

    Report

    Report Number
    1719045-2011-00283
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Report Date
    May 24, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED. SUBJECT DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING DATE WITHOUT A LOT NUMBER. ADDITIONAL INFO HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    FUSION HARDWARE WAS IMPLANTED IN 2007 (USS VAS3). PT EXPERIENCED ADJACENT LEVEL SEGMENT DISEASE. SURGEON REMOVED HARDWARE TO FUSE LEVEL L3-L5. NO ISSUE WITH THE HARDWARE. DURING SCREW REMOVAL, BONY OVERGROWTH WAS PRESENT AND HEADS WERE NOT EASY TO REMOBILIZE. SCREW STRIPPED DURING REMOVAL AND THE TIP OF THE EXTRACTION SCREW SHEARED OFF IN THE HEAD OF ONE OF THE SCREWS. AFTER FURTHER ATTEMPTS, SURGEON DECIDED TO LEAVE THE HARDWARE IN PLACE. THE CONSTRUCT WAS EXTENDED 1 LEVEL TO ADDRESS THE ADJACENT LEVEL DISC DISEASE. THIS IS THE 1ST OF 7 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONICAL EXTRACTION SCREW CONICAL EXTRACTION SCREW HWC SYNTHES MONUMENT NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention SCREW