BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 5194272 · Received November 2, 2015

    Report

    Report Number
    1030489-2015-02884
    Event Type
    Injury
    Date Received
    November 2, 2015
    Date of Event
    April 1, 2014
    Report Date
    October 19, 2015
    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

    ADDITIONAL INFORMATION: X-RAY ANALYSIS: ON SEGMENT SCOLIOSIS CORRECTION WITH FIXED ANGLE SCREW AND ROD CONNECTORS¿ SHOWS ONE OF THE BOTTOM CONNECTORS DETACHED FROM ROD AND THE SET SCREW LOOSE IN SOFT TISSUES. THE ROD IS INTACT. NOTED IN THE EVENT DESCRIPTION IS THE POSSIBILITY THAT THE SET SCREW WAS NOT APPROPRIATELY TIGHTENED. FUSION STATUS IS ALSO UNKNOWN. BOTH OF THESE MAY BE CONTRIBUTING FACTORS TO HARDWARE FAILURE. ROOT CAUSE SURGICAL TECHNIQUE.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 8292035, 510K # K031967 WAS CLEARED IN THE UNITED STATES. DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE RE PORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR SPINAL FIXATION AT LEVELS THORACIC(LEVEL UNKNOWN) TO L5 TO TREAT SCOLIOSIS DUE TO MARFAN SYNDROME. HE WAS (B)(6) AT THAT MOMENT. HE HAD ATOPY AS A COMORBIDITY. ON (B)(6) 2014, X-RAY REVEALED MIGRATION OF IMPLANT. REVISION WAS NOT DONE AT THAT TIME. ON AN UNKNOWN DATE, THE PATIENT DEVELOPED INFECTION AND SEPSIS. REMOVAL OF THE IMPLANT WAS PERFORMED. THE PATIENT IS BEING HOSPITALIZED. SURGEON COMMENTED THAT HE MIGHT HAVE TIGHTENED THE SET SCREW OF THE MIGRATED IMPLANT A BIT LOOSE THAT MIGHT HAVE CONTRIBUTED TO THE MIGRATION. IT WAS ADDITIONALLY REPORTED THAT THE PATIENT DEVELOPED ALLERGY -LIKE SYMPTOMS ABOUT 1 WEEK AFTER THE INITIAL SURGERY. DEBRIDEMENT WAS PERFORMED ON AN UNKNOWN DATE. THE SURGEON COMMENTED IT MIGHT BE CAUSED BY HIS ATOPY. A PLUG THAT WASN'T CONFIRMED ON IMAGE WAS FOUND AFTER OPENING THE WOUND. THE SURGEON COMMENTED THE EVENT OCCURRED AS HE DIDN'T TIGHTEN IT WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725724 TSRH SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention