BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 6232260 · Received January 9, 2017

    Report

    Report Number
    1030489-2017-00068
    Event Type
    Injury
    Date Received
    January 9, 2017
    Report Date
    December 15, 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 DEVICE IS NOT MARKETED IN US, HOWEVER, A SIMILAR DEVICE WITH PRODUCT ID 828-090, UPN# (B)(4) AND 510K# K964275 IS MARKETED IN US. (B)(4). 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.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    DATE OF INITIAL SURGERY: (B)(6) 2013 PRE-OP DIAGNOSIS FOR INITIAL SURGERY: SCOLIOSIS IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, THE ROD AT L4 BROKE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2016 TO CONNECT THE BROKEN PART USING CONNECTORS. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18767 TSRH SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention