BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIS CANNULATED POLYAXIAL SCREW 6X45MM,TI

    MDR report key: 3900021 · Received June 27, 2014

    Report

    Report Number
    1526439-2014-11642
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK033901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED POLYAXIAL SCREW FOUND DAMAGE WAS VISIBLE ON THE FIRST PAIR OF THREADS OF THE TULIP HEAD AS WELL AS ON ITS OUTER LIP. THE DAMAGE CONSISTS OF ROUGH, COMPRESSED EDGES. A 12 MONTH REVIEW OF THE COMPLAINT TREND ANALYSIS FOR THE PRODUCT FAMILY FOUND NO EMERGING TRENDS. A ROOT CAUSE CANNOT BE DETERMINED FROM THE SAMPLE AND THE INFORMATION PROVIDED. A POTENTIAL ROOT CAUSE IS CROSS-THREADING AS EVIDENCED BY THE DAMAGE TO THE TULIP HEAD. NO CORRECTIVE AND PREVENTIVE ACTION (CAPA) IS NECESSARY AT THIS TIME AS THERE HAVE BEEN NO ISSUES IDENTIFIED IN THE MANUFACTURING OF THESE PARTS. THEREFORE, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THREADS FROM THREE VIPER SCREWS (TWO MIS SINGLE INNER SET SCREWS AND ONE MIS CANNULATED POLYAXIAL SCREW) WERE DAMAGED WHILE TRYING TO USE A CONCOMITANT DEVICE TWO PIECE VIPER3D REDUCTION HANDLE. THE THREADS OF THE SCREWS WERE TORN FROM THE DEVICES AND FELL OFF INTO THE PATIENT. THE TORN THREADS WERE RETRIEVED FROM THE SURGICAL SITE. THE DIFFICULTY RESULTED IN THE PATIENT BEING UNDER ANESTHESIA FOR AN ADDITIONAL THIRTY MINUTES. THE FOLLOWING MFG. MEDWATCH REPORTS ARE BEING FILED FOR THE THREE SCREWS WITH TORN THREADS: 1526439-2014-11640, 1526439-2014-11641, 1526439-2014-11642.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377379 MIS CANNULATED POLYAXIAL SCREW 6X45MM,TI ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE ANCDNW

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR VIPER 3D REDUCTION HANDLE