BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 1636506 · Received March 19, 2010

    Report

    Report Number
    1030489-2010-00324
    Event Type
    Injury
    Date Received
    March 19, 2010
    Date of Event
    March 29, 2001
    Report Date
    February 19, 2010
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWQ
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). LITERATURE ARTICLE CITATION: RICHARDS ET AL. DELAYED INFECTIONS AFTER POSTERIOR TSRH SPINAL INSTRUMENTATION FOR IDIOPATHIC SCOLIOSIS. SPINE 2001; 26:18:1990-1996. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A REINSTRUMENTATION SURGERY DUE TO CURVE PROGRESSION. SHE DEVELOPED A RECURRENT INFECTION WITH P. ACNES 4 MONTHS AND 8 MONTHS AFTER THE REINSTRUMENTATION. THE WOUND WAS DEBRIDED AND THEN CLOSED PRIMARILY OVER INTACT INSTRUMENTATION, AND THE PT TOOK CLINDAMYCIN FOR 5 MONTHS. THE INCISION IN THE BACK HEALED WITHOUT REDNESS OR SWELLING AND REMAINED SO 2 YEARS AFTER THE REINSTRUMENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TSRH SPINAL SYSTEM HOOKS, RODS, SCREWS KWQ WARSAW ORTHOPEDIC INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention