BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEEK PREVAIL CERVICAL INTERBODY DEVICE

    MDR report key: 2071591 · Received April 28, 2011

    Report

    Report Number
    1030489-2011-00462
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH
    Product Code
    OVE
    PMA / PMN Number
    K073285
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAGE IS BROKEN AT THE BASE OF THE "ANCHOR" SHAPE WITH THE "PLATE" SHAPE. THE BROKEN SECTION IS OBLIQUE TO THE AXIS OF THE THREADED HOLE. THE LOCATION OF THE BROKEN SECTION IS CONSISTENT WITH THE END OF THE THREAD OF THE IMPLANT HOLDER SHAFT WHEN THE IMPLANT HOLDER IS CONNECTED TO THE CAGE. A CRACK SECONDARY TO THE BREAKAGE IS STARTING AT THE INNER THREAD AND PROPAGATING ALONG THE WALL TO ONE SCREW HOLE. TWO NOTCHES ARE PRESENT AT ONE SIDE OF THE CAGE NEAR THE SCREW HOLES. THEY CAN BE ATTRIBUTED TO THE TIP EDGES OF THE IMPLANT HOLDER WHEN LATERAL LOAD IS APPLIED DURING THE POSITION OR REPOSITION OF THE CAGE. THE THREADS OF BOTH THE "ANCHOR" AND THE "PLATE" PARTS ARE SHEARED OFF AND COME FROM THE LOAD APPLIED ON THE IMPLANT HOLDER DURING THE POSITION OR REPOSITION OF THE CAGE. ONE SHAVING AND TWO NOTCHES ARE PRESENT AT ONE SCREW HOLE ENTRANCE, ALONG THIS SCREW HOLE AND AT THIS SCREW HOLE EXIT. THE ORIGIN CANNOT BE DETERMINED WITH THE PROVIDED INFORMATION. NO PRE-EXISTING DEFECT HAS BEEN HAS BEEN IDENTIFIED AT THE LEVEL OF THE DAMAGES. THE OBSERVATION OF THE BROKEN SECTION AND THE DAMAGED THREAD INDICATE THAT THE BREAKAGE OF THE CAGE IS CONSISTENT WITH LATERAL OVER-LOADS APPLIED ON THE IMPLANT HOLDER DURING THE POSITION OR REPOSITION OF THE CAGE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTERBODY DEVICE BROKE DURING INSERTION. NO ADDITIONAL INFORMATION WAS PROVIDED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEEK PREVAIL CERVICAL INTERBODY DEVICE INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL OVE MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH TK73

    Patients

    Seq Age Sex Outcome Treatment
    1