BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHIR ANTERIOR CERVICAL SYSTEM

    MDR report key: 2110592 · Received June 1, 2011

    Report

    Report Number
    1030489-2011-00651
    Event Type
    Injury
    Date Received
    June 1, 2011
    Report Date
    May 31, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    K994239
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PLATE PRESENTS SEVERAL SCRATCHES AT ITS TOP SURFACE COMING FROM THE EXPLANTATION. THE FRACTURE OF ONE LOCKING CAP TIP IS ORTHOGONAL TO THE PLATE. THE FRACTURE APPEARANCE IS BRITTLE SUSPECTING A SUDDEN BREAKAGE. NO DEFECT WAS FOUND AT THE LEVEL OF THE BREAKAGE. THE DAMAGES OBSERVED ARE CONSISTENT WITH A SUDDEN BREAKAGE OF THE LOCKING CAP DUE TO FLEXION LOAD. THE ORIGIN OF THE OVERLOAD MAY COME FROM THE CAGE SUBSIDENCE INTO THE VERTEBRAL AND ASSOCIATED PSEUDOARTHROSIS. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIFICATION OR DEVIATIONS IN PROCEDURE WHICH MIGHT CONTRIBUTE TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A FUSION PROCEDURE. AN UNKNOWN TIME POST-OP, THE PLATE BROKE, CAUSING THE SCREW, OR PART OF IT, TO SLIDE OUT OF THE PLATE HOLE. THE PATIENT UNDERWENT A REVISION SURGERY. EVERYTHING WAS REMOVED ALTHOUGH PATIENT HAD NO COMPLAINTS, ILIAC CREST GRAFT WAS THEN INSERTED AT THE EXPLANTED LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZEPHIR ANTERIOR CERVICAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK 0015273W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention