BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 6002430 · Received October 6, 2016

    Report

    Report Number
    1030489-2016-02785
    Event Type
    Injury
    Date Received
    October 6, 2016
    Report Date
    September 6, 2016
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    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 UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 828-090, 510K # K964275 WAS CLEARED IN THE UNITED STATES. (B)(4) (REVISION SURGERY). NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    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 VERTEBRAL COLUMN RESECTION (VCR) SURGERY AT T4-IL LEVELS, FOR THE TREATMENT OF KYPHOSIS. POST-OPERATIVELY, ON AN UNKNOWN DATE, THE IMPLANTED ROD BROKE INSIDE THE PATIENT. REPORTEDLY, THE PATIENT UNDERWENT REVISION SURGERY, IN WHICH ROD WAS REPLACED AND AS A RESULT, TOTAL FOUR RODS WERE PLACED. NO FRAGMENTS OF THE BROKEN ROD REMAINED INSIDE THE PATIENT. REPORTEDLY, VCR PERFORMED AT TH12 HAD NOT ACHIEVED BONE UNION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658595 TSRH SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention