BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI NUT 11MM WIDTH ACROSS FLATS

    MDR report key: 3213942 · Received July 9, 2013

    Report

    Report Number
    2520274-2013-04086
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    KWP
    PMA / PMN Number
    K091689
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE FOR THIS REPORT INCLUDES MNI. IMPLANT UNKNOWN DATE IN 2008. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED AND NO LOT NUMBER WAS PROVIDED. THIS DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON PERFORMED A REVISION SURGERY ON A PATIENT THAT HAD A PREVIOUS L4-S1 POSTERIOR FUSION WITH SYNTHES USS, UNIVERSAL SPINE SYSTEM. THE PATIENT HAD ADJACENT LEVEL DISC DISEASE AT L3-4. HE REMOVED THE L4-S1 HARDWARE FROM THE 2008 SURGERY. THERE WERE NO ISSUES WITH THE OLD HARDWARE. HE THEN PLACED SYNTHES USS DUAL OPENING HARDWARE FROM L3-S1. DURING THE INTERBODY FUSION PART OF THE PROCEDURE AT L3-4, HE BROKE THE GRAFT PUSHER HANDLE. ALL FRAGMENTS OF THE HANDLE WERE RETRIEVED AND THE INTERBODY FUSION WAS COMPLETED WITHOUT AN ISSUE. LATER IN THE PROCEDURE WHEN CONNECTING THE RODS, THE SURGEON STRIPPED THE TOP THREADS OF THE LEFT L3 SCREW WHEN SECURING THE NUT AND COLLAR. HE ATTEMPTED TO USE ANOTHER NUT AND COLLAR TO SECURE THE ROD, BUT THE SCREW THREADS WERE STRIPPED SO HE REPLACED THE SCREW AND WAS SUCCESSFULLY ABLE TO SECURE THE ROD WITH A NEW NUT AND COLLAR. AROUND 15 -20 MINUTES WAS ADDED TO THE PROCEDURE AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 26 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313957 TI NUT 11MM WIDTH ACROSS FLATS KWP SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention