BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH

    MDR report key: 5530828 · Received March 29, 2016

    Report

    Report Number
    1030489-2016-00804
    Event Type
    Injury
    Date Received
    March 29, 2016
    Report Date
    April 25, 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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS :VISUAL REVIEW OF RETURNED IMPLANT IDENTIFIED SPLINE DEFORMATION CONSISTENT WITH EXPLANTATION. NO DAMAGE OR DE FORMATION NOTED TO BONE SCREW THREAD PORTION OF THE IMPLANT. DIMENSIONAL INSPECTION OF MAJOR AND MINOR DIAMETER CONFIRM CONFORMANCE TO PRINT SPECIFICATION. AFTER VISUAL, OPTICAL AND DIMENSIONAL INSPECTION, NO EVIDENCE WAS FOUND THAT WOULD SUGGEST A DEFECT IN MANUFACTURING OF THE IMPLANT OR ASSOCIATED COMPONENTS; UNABLE TO DETERMINE ROOT CAUSE OF THE FOREGOING EVENT FROM THE AVAILABLE INFORMATION. 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.

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR PRODUCT WITH CATALOG #8293645 AND 510K# K030285 IS APPROVED FOR SALE IN US. (B)(4) (REVISION SURGERY). NEITHER THE PRODUCT NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE CAUSE OF EVENT CANNOT BE DETERMINED. 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PRE-OP DIAGNOSIS: IDIOPATHIC SCOLIOSIS INITIAL SURGERY: POSTERIOR CORRECTION FUSION LEVELS: T10-L3 IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, SCREW BACKED OUT SO PATIENT UNDERWENT REVISION SURGERY IN WHICH IT WAS REPLACED THE SCREW WITH A HOOK.THE SURGEON TOLD THAT THE SCREWS BACKED OUT BECAUSE THE PATIENT HAD LOTS OF PHYSICAL ACTIVITIES LIKE PLAYING SOCCER AND SWIMMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187188 TSRH APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0284206W

    Patients

    Seq Age Sex Outcome Treatment
    1 00017 YR Required Intervention