BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 5453218 · Received February 23, 2016

    Report

    Report Number
    1030489-2016-00520
    Event Type
    Injury
    Date Received
    February 23, 2016
    Report Date
    March 30, 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

    (B)(6). (B)(4). THIS PART IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG # 811-300 AND 510K #K982990 IS APPROVED FOR SALE IN US. NEITHER THE DEVICE NOR APPLICABLE IMAGING DEVICES WERE RETURNED TO MANUFACTURER FOR EVALUATION, THEREFORE UNABLE TO DETERMINE DEFINITIVE CAUSE OF EVENT.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS :VISUAL, OPTICAL AND MICROSCOPIC EXAMINATION OF THE CONNECTORS IDENTIFIED THE DEFORMATION OF THE ROD HOLES CONSISTENT WITH SUB-CRITICAL OVERLOAD. THIS OVERLOAD COULD CONTRIBUTE TO SUBSEQUENT LOOSENING OF THE SET SCREWS IF SET SCREW-TO-ROD CONTACT WAS COMPROMISED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2014: THE PATIENT WITH SPINAL STENOSIS AND DEGENERATIVE SCOLIOSIS UNDERWENT POSTERIOR FUSION AT T10 TO ILIUM AND INTERBODY FUSION AT L1 TO SACRUM. ON (B)(6) 2015: FIXATION WAS EXTENDED TO T4 WITH THE USE OF THE MEDICAL DEVICE (SPINAL CONNECTORS). AND THEN, THE SCREW IMPLANTED AT T10 WAS REMOVED AND THE RODS WERE CONNECTED WITH THE USE OF SPINAL SCREWS. ON (B)(6) 2016: THE PATIENT HEARD AN ABNORMAL SOUND AND EXPERIENCED BACK PAIN WHEN TWISTED THE BODY. ON (B)(6) 2016: THE FOLLOWING EVENTS WERE OBSERVED: NON-UNION AT T9 AND T10; LOOSENING OF THE SPINAL SCREWS IMPLANTED AT THE BOTH SIDES OF T4 AND T5, AND THE RIGHT SIDE OF T9; LOOSENING OF THE SPINAL CONNECTOR. FOR THESE ADVERSE EVENTS, REVISION WAS PERFORMED FOR REPLACEMENT OF LOOSENED SCREWS, LOOSENED CONNECTOR, AND ROD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110756 TSRH SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0286587W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention