BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIPER TI SAI POLY 9X100MM

    MDR report key: 8307023 · Received February 5, 2019

    Report

    Report Number
    1526439-2019-51312
    Event Type
    Injury
    Date Received
    February 5, 2019
    Date of Event
    January 16, 2019
    Report Date
    January 16, 2019
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    NKB
    UDI-DI
    10705034265889
    PMA / PMN Number
    K111571
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # ==> (B)(4). VISUAL EXAMINATION FOUND THAT THE THREADS ON THE SCREW¿S TULIP HEAD WAS COMPLETELY TORN OFF. 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 9X100MM 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 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

    IT WAS REPORTED THAT THE PELVIC FIXATION SURGERY WAS PERFORMED ON (B)(6). WHEN THE SURGEON INSERTED THE SCREW FROM THE PATIENT'S LEFT SACRUM INTO THE ILIUM, THE SURGEON RECOGNIZED THE STRANGE NOISE, AND THEN FOUND THE BROKEN FRAGMENT (LIKE SCREW THREAD) IN THE SCREW HEAD. THUS, THE SURGEON REMOVED THE BROKEN FRAGMENT. THEN, THE SURGEON ATTEMPTED FINAL TIGHTENING WITH SET SCREW; HOWEVER, THE SET SCREW WAS SPIN IDLED. THE SURGERY WAS COMPLETED BY USING ALTERNATIVE SCREW (P/N AND LOT # WERE UNKNOWN). THERE WAS LESS THAN 30 MIN. 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
    99342 VIPER TI SAI POLY 9X100MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDOS INTERNATIONAL SàRL CH 179704999 TBTWA 10705034265889

    Patients

    Seq Age Sex Outcome Treatment
    1 Other