BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7.0MM TI PANGEA POLY NAIL

    MDR report key: 2983010 · Received February 26, 2013

    Report

    Report Number
    2530088-2013-10054
    Event Type
    Malfunction
    Date Received
    February 26, 2013
    Date of Event
    April 13, 2011
    Report Date
    April 13, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K082572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED (B)(4) 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFO RECEIVED REGARDING EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. DHR REVIEW PERFORMED: A REVIEW OF THE SYNTHES DEVICE HISTORY RECORDS FOR MFG REVEALED NO COMPLAINT RELATED ISSUES. SCREW ASSEMBLY RECEIVED WITH BODY NOT ATTACHED TO SCREW. VISUAL INSPECTION SHOWED DAMAGE TO THE BODY. THERE IS AN IMPRINT ON ID "CHAMFER" WHERE SCREW WAS "LEVERED" FROM BODY. SCREW HEAD HAS DEFORMATION IN GROOVE AREA THAT WOULD ENGAGE WITH COLLET. ALSO, T25 STARDRIVE HAS EXTENSIVE INTERNAL DAMAGE. COLLET SPHERICAL ID HAS GALLING AND DEFORMATION THAT WOULD BE SIMILAR TO GROOVES ON SCREW. THESE NONCONFORMITIES ARE POST MANUFACTURING. THIS COMPLAINT IS INVALID.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PLIF PROCEDURE AT LEVELS L5-S1 WHEN INSERTING SCREW, THE SURGEON LEANED ON THE SCREWDRIVER AT AN ANGLE IN AN ATTEMPT TO REDIRECT THE SCREW. AS A RESULT, THE SCREW HEAD CAME OFF. SURGEON REMOVED THE REMAINING PART OF THE SCREW AS WELL AS THE BROKEN PIECE. SCREW WAS REPLACED WITH ANOTHER AND COMPLETED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81344 7.0MM TI PANGEA POLY NAIL NKB SYNTHES BRANDYWINE 6600439

    Patients

    Seq Age Sex Outcome Treatment
    1