BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 10146842 · Received June 12, 2020

    Report

    Report Number
    1030489-2020-00603
    Event Type
    Injury
    Date Received
    June 12, 2020
    Report Date
    June 11, 2020
    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 AND UDI # (B)(4) WAS CLEARED IN THE UNITED STATES. 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 PRESENTED WITH KYPHOSCOLIOSIS; AND UNDERWENT FIXATION FROM T8 TO ILIAC. ON AN UNKNOWN DATE, POST-OP, THE ALLEGED ROD BROKE AT LEFT SIDE OF SACRAL-ILIAC JUNCTION. THE RIGHT SIDE ROD ALSO BROKE AT SACRAL-ILIAC JUNCTION. ADDITIONALLY, NON-UNION WAS OBSERVED AT L4-L5. HENCE, A REVISION SURGERY WAS PERFORMED, IN WHICH THE BROKEN RODS WERE REPLACED AND REINFORCEMENT WAS PERFORMED WITH FOUR RODS. NO FRAGMENT OF THE BROKEN RODS REMAINED INSIDE THE PATIENT. PATIENT'S ISSUE HAS BEEN REPORTED AS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613239 TSRH SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention