BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 10357115 · Received August 3, 2020

    Report

    Report Number
    1030489-2020-01024
    Event Type
    Malfunction
    Date Received
    August 3, 2020
    Report Date
    August 3, 2020
    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

    PMA/510K: THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 8292035, UDI# (B)(4), 510K #K031967 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PRE OP DIAGNOSIS: FALSE JOINT OCCURRED POST OP, CONNECTOR COME OFF AT MULTIPLE PLACES AFTER FINAL TIGHTENING. THE PATIENT HAD DIFFICULTY IN BOTH STANDING AND SITTING FOR A LONG TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821678 TSRH SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention