BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.0MM TI MATRIX POLYAXIAL SCREW 45MM THREAD LENGTH

    MDR report key: 3180906 · Received June 20, 2013

    Report

    Report Number
    2530088-2013-00948
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 22, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. SCREW / BODY RECEIVED ASSEMBLED. ON THE SCREW, PART OF THE M6.5 X 0.75-6H THREAD IS PEELED. THERE ARE NICKS AND SCRATCHES ON THE SD25 FACE AND DEFORMATION IN THE FORM. ALL DESCRIBED NONCONFORMITIES ARE POST MANUFACTURING. NEITHER THE SPHERICAL OUTER DIAMETER ON THE SCREW NOR THE SPHERICAL INTERNAL DIAMETER ON THE COLLET CAN BE MEASURED BECAUSE OF ASSEMBLED CONDITION AND MANUFACTURING CONDITIONS - OUTER DIAMETER CAN ONLY BE MEASURED PRIOR TO BEAD BLAST AND INTERNAL DIAMETER CANNOT BE MEASURED IN MANUFACTURED SPLIT CONDITION. PARTIALLY PEELED M6.5 X 0.75-6H THREAD WOULD NOT CAUSE POP OFF. PRODUCT IS DESIGNED TO POP-OFF AND RE-ASSEMBLE. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    SHOULD BE REPORT 1 OF 1 FOR COMPLAINT # (B)(4) INSTEAD OF 1 OF 2 REPORTS AS STATED ON THE INITIAL REPORT SUBMITTED ON (B)(6) 2013. ONLY 1 MEDWATCH REPORT IS ASSOCIATED WITH THE REPORTED EVENT.

    Description of Event or Problem · 1

    DURING A POSTERIOR LUMBAR FUSION PROCEDURE AT L4-L5, THE SURGEON INSERTED A PEDICLE SCREW IN THE L4 LEFT PEDICLE, THEN IMMEDIATELY TRIED TO REMOVE AND REPOSITION IT. WHEN HE TRIED TO REPOSITION IT, THE HEAD OF THE SCREW POPPED OFF. BOTH PIECES OF THE SCREW WERE RETRIEVED, AND THE SURGEON REPLACED THE SCREW AND COMPLETED THE PROCEDURE WITH NO FURTHER PROBLEM. NO DELAY IN SURGERY AND NO ADDITIONAL MEDICAL INTERVENTION REQUIRED. THE SURGERY WAS SUCCESSFULLY COMPLETED AND THE PATIENT IS REPORTEDLY RECOVERING WELL. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT, COMPLAINT # (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280314 6.0MM TI MATRIX POLYAXIAL SCREW 45MM THREAD LENGTH ORTHOSIS SPINAL PEDICLE NKB SYNTHES BRANDYWINE 6902149

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR