BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENOR SPINAL SYSTEM

    MDR report key: 1571631 · Received December 11, 2009

    Report

    Report Number
    1030489-2009-01165
    Event Type
    Malfunction
    Date Received
    December 11, 2009
    Date of Event
    November 18, 2009
    Report Date
    November 18, 2009
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): WE ARE UNABLE TO DETERMINE THE SUSPECT DEVICES. THE PEDICLE SCREWS IN USE WERE LOT # W06F0963 AND W06G3846. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 806R55L45T, 510K # K991528 WAS CLEARED IN THE UNITED STATES. THE MANUFACTURE DATE FOR LOT W06F0963 IS 07/18/2006 AND THE MANUFACTURE DATE FOR LOT W06F3846 IS 08/28/2006. IMPLANT REMAINED IMPLANTED, PRODUCT EVALUATION IS NOT POSSIBLE. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE TO FUSE T9-T12 USING POSTERIOR FIXATION. THE T12 SET SCREW WAS STUCK DURING IMPLANTATION, THEREFORE, IT WAS REMOVED. IT WAS FOUND AFTER THE SET SCREW WAS REMOVED THAT BOTH SET SCREW AND THE PEDICLE SCREW POST WERE DAMAGED. THE SURGEON CUT THE PEDICLE SCREW POST TRYING TO IMPLANT A NEW SET SCREW, HOWEVER, THE REMAINED SCREW POST WAS TOO SHORT TO ENGAGE WITH ANY SET SCREWS. THE SURGEON DID NOT REPLACE THE PEDICLE SCREW DUE TO CONCERNING POTENTIAL EXTENSION OF THE SURGICAL TIME. THEREFORE, T12 DID NOT HAVE THE SET SCREW BEING IMPLANTED. NO FURTHER COMPLICATIONS WERE REPORTED FOR THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENOR SPINAL SYSTEM BONE SCREW KWQ WARSAW ORTHOPEDIC, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70+ SET SCREW CATALOG # G806ECT