BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 6897765 · Received September 27, 2017

    Report

    Report Number
    1030489-2017-02125
    Event Type
    Injury
    Date Received
    September 27, 2017
    Report Date
    August 30, 2017
    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

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 8293525, 510K #K030285 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR CORRECTION FUSION AT T2-L4 FOR SCOLIOSIS. POST-OP, LOOSENING OF THREE SCREWS AND A HOOK AT THE LOWER END OF THE FIXED RANGE WERE FOUND. THE PATIENT'S PEDICLE WAS VERY THIN. IN THE REVISION SURGERY, ONE OF THE OF THE THREE LOOSENED SCREWS WAS REPLACED TO 5.5×30 MM. THE HOOKS WERE USED AS THE SUBSTITUTES FOR THE REST OF TWO. ROD WAS EXTENDED AT THE LEVEL AT WHICH THE SCREW COULD NOT BE INSERTED, AND CROW HOOK PROCEDURE WAS PERFORMED TO MAINTAIN THE FIXING FORCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677062 TSRH SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention