BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 8393863 · Received March 6, 2019

    Report

    Report Number
    1030489-2019-00233
    Event Type
    Injury
    Date Received
    March 6, 2019
    Report Date
    March 6, 2019
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NKB
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE US, HOWEVER A LIKE DEVICE WITH PART# 83565459, 510K# K090740 AND UPN (B)(4) IS APPROVED FOR SALE. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT DECOMPRESSION AT L4/5 AND PERFORMED FIXATION TO L3-5 DUE TO STENOSIS. POST-OP, NEUROLOGICAL SYMPTOM OCCURRED ON THE RIGHT OF L5. WHEN THE PATIENT MOVED, THERE WAS FEELING OF PALSY. THE IMPLANTED SCREW DEVIATED AND COMPRESSED THE NERVE. REVISION SURGERY WAS PERFORMED AND DIRECTION OF THE SCREW ON THE RIGHT OF L5 WAS ADJUSTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188536 TSRH SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB WARSAW ORTHOPEDICS NA 0579341W

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other| R