BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.0MM TI HARD ROD 50MM

    MDR report key: 3201048 · Received July 2, 2013

    Report

    Report Number
    2520274-2013-03929
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 4, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    KWQ
    PMA / PMN Number
    K943725
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT FOR DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. REVIEW OF MANUFACTURING RECORDS HAS BEEN REQUESTED. DATE OF ORIGINAL IMPLANT REPORTED ONLY AS 2010.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS IS 1 OF 25 REPORTS FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH SYNTHES USS FOR L2-L3 POSTERIOR LUMBAR FUSION IN 2010. PATIENT DEVELOPED ADJACENT LEVEL DISEASE CAUDAL TO THE SOLID L2-L3 LUMBAR FUSION. PATIENT WAS RETURNED TO OR ON (B)(6) 2013 FOR REMOVAL OF ALL HARDWARE. PATIENT WAS REVISED TO USS DUAL OPENING FROM L2-ILIUM. SURGEON ENCOUNTERED ISSUES WITH CONNECTING THE NUT AND COLLAR ONTO THE LEFT ILIAC SCREW WHEN THE TOP THREADS ON THE SCREW THAT CONNECT WITH THE NUT STRIPPED. THE SURGEON THEN RECANNULATED THE ILIUM AND REPLACED THE LEFT ILIAC SCREW WITH A 7 X 60MM SCREW, AS WELL AS THE COLLAR AND NUT, BUT ENCOUNTERED THE SAME ISSUE WITH THE THREADS STRIPPING. THE SURGEON THEN REPLACED THE SECOND STRIPPED SCREW WITH A LARGER DIAMETER 8 X 60MM SCREW, AS WELL AS THE COLLAR AND NUT, BUT AGAIN, THE SCREW STRIPPED WHEN TRYING TO ENGAGE THE NUT. THE SURGEON REPLACED THE THIRD STRIPPED SCREW WITH ANOTHER, AS WELL AS THE COLLAR AND NUT, AND WAS FINALLY ABLE TO GET THE NUT TO SUCCESSFULLY THREAD ONTO THE SCREW. IT IS REPORTED ONE HOOK AND SCREW HOLDER WAS FOUND TO BE BENT DURING THE PROCEDURE. THIS IS REPORT 1 OF 14 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THE PROCEDURE WAS EXTENDED BEYOND 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303305 6.0MM TI HARD ROD 50MM KWQ SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention