BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIPER TI SAI POLY 8X80MM

    MDR report key: 8039227 · Received November 5, 2018

    Report

    Report Number
    1526439-2018-51046
    Event Type
    Injury
    Date Received
    November 5, 2018
    Date of Event
    October 25, 2018
    Report Date
    October 25, 2018
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    NKB
    UDI-DI
    10705034265728
    PMA / PMN Number
    K111571
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). A COMPLAINT INVESTIGATION WILL BE PERFORMED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE COMPLAINT INVESTIGATION IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT FILED WITH THE RESULTS. 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

    (B)(4). VISUAL EXAMINATION FOUND THAT THE THREADS ON THE POLYAXIAL SCREW WERE TORN. NOTED DAMAGE SUGGESTS THAT INADVERTENTLY CROSS THREADING OF THE SETSCREW OCCURRED UPON INSERTION INTO THE TULIP HEAD. 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. WITH THE INFORMATION PROVIDED, A DEFINITIVE ROOT CAUSE FOR THE TORN THREADS ON THE VIPER TI SAI POLY 8X80MM CANNOT BE DETERMINED. 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

    (B)(4). DEVICE WAS RECEIVED FOR EVALUATION. INVESTIGATION WILL BE COMPLETED. FOLLOW UP WILL BE FILED WITH THE INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW HEAD OF THE SAI WAS BROKEN DURING POSTERIOR LUMBAR FUSION SURGERY ON (B)(6) 2018. FIRST, THE SURGEON FELT DIFFICULTY TO INSERT THE SCREW INTO THE PATIENT¿S BODY, SO THAT THE SURGEON USED VBD REDUCTION INSTRUMENT TO INSERT THE SCREW. HOWEVER, THE AT THE FINAL FIXATION OF THE SCREWS, THE REPORTED SCREW WAS NOT PROPERLY INSERTED. THEN, THE SURGEON RECOGNIZED THAT THE SCREW HEAD WAS BROKEN. THE SURGERY WAS COMPLETED BY USING ALTERNATIVE SCREW (P/N AND LOT NUMBER WERE UNKNOWN). THE SURGEON CONFIRMED THAT THERE WERE NO BROKEN PARTS IN THE PATIENT¿S BODY, DURING AND AFTER THE SURGERY UNDER X-RAY. THERE WAS LESS THAN 30MIN. SURGICAL DELAY AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880294 VIPER TI SAI POLY 8X80MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDOS INTERNATIONAL SàRL CH 179704880 TBMPJ 10705034265728

    Patients

    Seq Age Sex Outcome Treatment
    1 Other