BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 2132558 · Received June 10, 2011

    Report

    Report Number
    2520274-2011-00197
    Event Type
    Injury
    Date Received
    June 10, 2011
    Report Date
    May 24, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    KWP
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED. APPROXIMATE IMPLANT DATE REPORTED AS 2007. SYNTHES IS UNABLE TO DETERMINE MFG SITE OR MFG DATE WITHOUT A PART NUMBER OR A LOT NUMBER. SYNTHES IS UNABLE TO DETERMINE 510(K) # WITHOUT A PART NUMBER OR LOT NUMBER. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED.

    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 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 5TH OF 7 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI ROD KWP SYNTHES (USA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention SCREWS| RODS| CAPS