BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIPER TI SAI POLY 8X90MM

    MDR report key: 7477036 · Received May 1, 2018

    Report

    Report Number
    1526439-2018-50446
    Event Type
    Malfunction
    Date Received
    May 1, 2018
    Date of Event
    April 11, 2018
    Report Date
    April 11, 2018
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    NKB
    UDI-DI
    10705034265742
    PMA / PMN Number
    K160904
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). VISUAL EXAMINATION FOUND THAT THE INITIAL THREADS ON THE POLYAXIAL¿S TULIP HEAD HAD BECOME TORN OFF. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. ALL COMPLAINT TRENDS WILL BE EVALUATED AS A PART OF THE DEPUY SPINE MONTHLY COMPLAINT REVIEW MEETING. A DEFINITIVE ROOT CAUSE FOR THE TULIP HEAD THREADS BECOMING TORN OFF CANNOT BE POSITIVELY DETERMINED. HOWEVER, THE NOTED DAMAGE SUGGESTS THAT INADVERTENTLY CROSS THREADING OF THE SETSCREW OCCURRED UPON INSERTION INTO THE TULIP HEAD. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER AND NO SYSTEMIC TRENDS WERE FOUND, THIS COMPLAINT FILE 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.

    Additional Manufacturer Narrative · 1

    DEVICE IS AVAILABLE FOR EVALUATION. INVESTIGATION WILL BE CONDUCTED. FOLLOW UP WILL BE FILED WITH THE INVESTIGATION RESULTS. 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

    ON (B)(6) 2018, THE SURGERY FOR PELVIC FRACTURE WAS PERFORMED BY USING THE EXPEDIUM SYSTEM. THE FIXED AREA WAS AT S2 - AI. DURING THE SURGERY, THE SURGEON NOTICED THAT A SET SCREW COULD NOT BE TIGHTENED INTO SAI POLYAXIAL SCREW (179704890) BECAUSE THE HEAD OF SAI POLYAXIAL SCREW WAS BROKEN. TO COMPLETE THE PROCEDURES, HE REPLACED THIS BROKEN SCREW WITH A NEW ONE. NO BROKEN PIECES WERE FOUND LEFT IN THE BODY, AND THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A LESS-THAN-30-MINUTE DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319682 VIPER TI SAI POLY 8X90MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDOS INTERNATIONAL SàRL CH 179704890 TBPTV 10705034265742

    Patients

    Seq Age Sex Outcome Treatment
    1