BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 5353432 · Received January 8, 2016

    Report

    Report Number
    1030489-2016-00098
    Event Type
    Malfunction
    Date Received
    January 8, 2016
    Report Date
    December 15, 2015
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). MULTIPLE PRODUCTS USED IN THE EVENT. IT IS UNKNOWN WHICH PRODUCT CAUSED THE EVENT. (B)(4)(QUANTITY-2), LOT NUMBER: UNKNOWN. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG #811-300, 510K # (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT UNDERWENT CORRECTION AT TH2-L3 FOR IDIOPATHIC SCOLIOSIS. DURING SURGERY, SOFT TISSUE NEAR IMPLANT CONVEX SIDE WAS TURNED BLACK WHEN IT WAS OPENED TO EXTEND GROWING ROD. THE SURGEON COMMENTED IT MIGHT BE METALLOSIS AND WILL SEND THE TISSUE TO A LABORATORY FOR CULTURE. PATIENT COMPLICATIONS WERE UNKNOWN. IT WAS REPORTED THAT THE DISCOLORATION WAS CONFIRMED ONLY AROUND THE DOMINO OF CONVEX SIDE. IT WAS UNKNOWN HOW MANY TIMES HAS THE PATIENT UNDERWENT THE OPERATION. EVENT WAS OCCURRED POST-OP. METALLOSIS WAS SUSPECTED IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13045 TSRH SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00010 YR