BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5MM TAP (STAINLESS STEEL)

    MDR report key: 4903874 · Received July 9, 2015

    Report

    Report Number
    2027467-2015-00123
    Event Type
    Malfunction
    Date Received
    July 9, 2015
    Date of Event
    July 28, 2014
    Report Date
    June 12, 2015
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    HWX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MDR BEING SUBMITTED AS A RESULT OF A RETROSPECTIVE COMPLAINT REVIEW. NO EVALUATION POSSIBLE. THE USER FACILITY WOULD NOT RELEASE THE INSTRUMENT DUE TO THEIR INTERNAL INVESTIGATION. ALTHOUGH THE INSTRUMENT IN QUESTION WAS NOT RETURNED FOR EVALUATION, A PREVIOUS INVESTIGATION FOR THIS TYPE OF EVENT FOUND THE DESIGN OF FLUTE DEPTH AND GEOMETRY, AS WELL AS EPOXY GROOVE GEOMETRY WAS INAPPROPRIATE FOR THIS APPLICATION. CONTRIBUTING FACTORS INCLUDE SURGICAL TECHNIQUE AND MISUSE, PATIENT BONE QUALITY, IMPROPER MEASUREMENT TECHNIQUE OF THE FLUTES. AN UPDATE OF THE DIMENSIONS AND MATERIAL OF THE ARSENAL TAPS AND HAS BEEN IMPLEMENTED TO REDUCE THIS TYPE OF EVENT. ADDITIONALLY, FURTHER INVESTIGATION ON IMPROVING INSPECTION METHODS IN COLLABORATION WITH VENDOR HAS IDENTIFIED POTENTIAL FOR SIGNIFICANT IMPROVEMENT IN INSPECTION METHOD. CURRENT ACCEPTED INSPECTION PROCESS IS IN PLACE.

    Description of Event or Problem · 1

    THE ARSENAL TAP BROKE IN THE PATIENTS S1 PEDICLE. THE DETACHED PART WAS REMOVED FROM PEDICLE AND IT APPEARS THAT NO LOOSE FRAGMENTS REMAIN IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446231 5.5MM TAP (STAINLESS STEEL) HWX HWX ALPHATEC SPINE INC 87007-055 7099603

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| O