BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 1556386 · Received December 4, 2009

    Report

    Report Number
    1030489-2009-01148
    Event Type
    Malfunction
    Date Received
    December 4, 2009
    Date of Event
    November 12, 2009
    Report Date
    November 12, 2009
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 8281248, 510K # K041282 WAS CLEARED IN THE UNITED STATES. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL PROCEDURE TO IMPLANT POSTERIOR FIXATION AT T9 TO L3. IT WAS REPORTED THAT THE PLUGS COULD NOT BE BROKEN OFF AT LEFT T12 AND RIGHT L2. THE SURGEON DID NOT IMPLANT THE PLUGS AT T12 AND L2. THE SURGEON STATED THAT HE HAD ADDED TOO MUCH FORCE ONTO THE SET SCREW WHEN HE TIGHTENED THE SCREW. THE SET SCREW REPORTEDLY MIGHT HAVE BEEN CROSS THREADED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TSRH SPINAL SYSTEM LOCKSCREW KWP WARSAW ORTHOPEDIC INC. NA 0036874W

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR T BOLT CATALOG: # G8292036, LOT# #0036874W,| 0030760W