BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIPER TI SAI POLY 9X70MM

    MDR report key: 8258406 · Received January 17, 2019

    Report

    Report Number
    1526439-2019-51242
    Event Type
    Injury
    Date Received
    January 17, 2019
    Date of Event
    December 26, 2018
    Report Date
    December 26, 2018
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    NKB
    UDI-DI
    10705034265827
    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 OF THE SCREW REVEALED SIGNS OF OPERATIVE USE AS EVIDENCE BY SUPERFICIAL MARKINGS, WITH THREADS AND DRIVE FEATURE SLIGHTLY WORN. ROD STRIATIONS WERE OBSERVED ON THE SADDLE SUGGESTING THAT IT DID HAVE A TIGHT FIT. NO OTHER ABNORMALITIES WERE OBSERVED IN THIS ANALYSIS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF THE INSTRUMENT CONTRIBUTION TO THE REPORTED PROBLEM. IT IS NOT SUSPECTED THAT THE INSTRUMENT FAILED TO MEET ITS SPECIFICATIONS. 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. THE ROOT CAUSE ANALYSIS FOR THE VIPER TI SAI POLYAXIAL 9X70MM IS NOT NECESSARY. THE REPORTED CONDITION COULD NOT BE CONFIRMED AS NO DEFECT OR DAMAGES WAS FOUND ON THE DEVICE DURING THE EVALUATION. 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

    PRODUCT COMPLAINT # (B)(4). PC: SURGICAL INTERVENTION IN THE FORM OF REVISION SURGERY. (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.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # ==> (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2018, A SPINAL FUSION SURGERY (PRIMARY SURGERY) FOR SCOLIOSIS WAS PERFORMED WITH CANNULATED SAI POLYAXIAL SCREW IN QUESTION. THE SCREW WAS INSERTED IN S2 SPINE IN ACCORDANCE WITH SURGICAL TECHNIQUE IN THE PRIMARY SURGERY. ON (B)(6) 2018, THE SECONDARY PROCEDURE WAS PERFORMED. DURING THE PROCEDURE, THE SURGEON FOUND THAT THE SCREW FELL OUT FROM THE ROD. THE SURGEON REPLACED THE SCREW WITH ANOTHER POLYAXIAL SCREW (10 MM IN DIAMETER) IN THE SURGERY. THERE WAS NO SURGICAL DELAY AND 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
    50305 VIPER TI SAI POLY 9X70MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDOS INTERNATIONAL SàRL CH 179704970 TBKXS 10705034265827

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention