BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 2311641 · Received October 27, 2011

    Report

    Report Number
    1030489-2011-01375
    Event Type
    Malfunction
    Date Received
    October 27, 2011
    Report Date
    September 29, 2011
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE, PART NUMBER 8372740, 510K # K984522, IS APPROVED FOR USE. THE DEVICE OR APPLICABLE IMAGING STUDIES HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO INFORMATION TO INDICATE A NON-CONFORMANCE TO SPECIFICATION. UNABLE TO DETERMINE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REVISION SURGERY TO REPLACE AN INTERBODY DEVICE, THE SURGEON NOTICED TWO SCREWS BILATERAL AT S1 WERE LOOSE. THE SCREWS WERE REMOVED AND THEN REPLACED AFTER THE SCREW HOLES WERE FILLED WITH HYDROXYAPATITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TSRH SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS 0118584W

    Patients

    Seq Age Sex Outcome Treatment
    1