BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIPER TI SAI POLY 9X80MM

    MDR report key: 12319694 · Received August 13, 2021

    Report

    Report Number
    1526439-2021-01681
    Event Type
    Injury
    Date Received
    August 13, 2021
    Report Date
    July 15, 2021
    Manufacturer
    DEPUY SPINE INC
    Product Code
    NKB
    UDI-DI
    10705034265841
    PMA / PMN Number
    K160904
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL PRODUCT CODE: KWP; MNH; MNI. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW /INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. THE PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT: A REVIEW OF THE RECEIVING INSPECTION (RI) FOR EXP 5.5 TI SAI POLY 9X80 MM WAS CONDUCTED IDENTIFYING THAT LOT NUMBER TBWMT WAS RELEASED IN A SINGLE BATCH. BATCH 1: LOT QTY OF (B)(4) UNITS WERE RELEASED ON SEP 13, 2018 WITH NO DISCREPANCIES. AS A RESULT, THE RI IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. DEVICE HISTORY REVIEW: THE RI IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT UNDERWENT FOR REVISION PROCEDURE (L3-S) DUE TO SUFFERED FROM ASD AT L3. WHEN THE REVISION PROCEDURE (L3-S) WAS PERFORMED, SCREW LOOSENING WAS REVEALED, WHICH WAS REPLACED WITH A NEW SCREW. IT WAS UNKNOWN IF THE REVISION SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THE PRIMARY OLIF AND TLIF (L3-SAI) WERE PERFORMED ON (B)(6) 2019. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR (1) VIPER TI SAI POLY 9X80 MM. THIS REPORT IS 1 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1217772 VIPER TI SAI POLY 9X80MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB DEPUY SPINE INC 179704980 TBWMT 10705034265841

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention