BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAVE O CAGE

    MDR report key: 2990321 · Received March 5, 2013

    Report

    Report Number
    3003529816-2013-00007
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 2013
    Manufacturer
    ADVANCED MEDICAL TECHNOLOGIES
    Product Code
    MAX
    PMA / PMN Number
    K121330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). LOCATION: HOSPITAL. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    VISUALLY CONFIRMED ONE OF THE IMPLANTS BROKEN INTO MULTIPLE PIECES. SIGNIFICANT PLASTIC DEFORMATION IDENTIFIED AT THE INSERTER INTERFACE, ON THE OTHER RETURNED IMPLANT. MICROSCOPIC EXAMINATION OF BOTH RETURNED IMPLANTS PROVIDES EVIDENCE OF FRACTURE INITIATION AT THE BASE OF THE INSERTER INTERFACE FEATURES, WITH PLASTIC DEFORMATION AND EVIDENCE OF FRACTURE INITIATION. FRACTURE SURFACE EXAMINATION IDENTIFIED MULTIPLE QUASI-BRITTLE SURFACES WITH RAYS EMANATING FROM LIKELY FRACTURE INITIATION POINTS SUGGESTING THE DIRECTION AND LOCATION OF FRACTURE, CONSISTENT WITH OVERLOAD. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH OVERLOAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TLIF PROCEDURE AT L5-S1, THE PEEK CAGE BROKE INTO 3 PIECES DURING INSERTION. THE BROKEN PIECES WERE REMOVED AND A SECOND CAGE OF THE SAME SIZE WAS PLACED ON THE INSERTER. THE SECOND BROKE AT THE JUNCTION OF THE INSERTER AND CAGE AND REMAINED IN ONE PIECE. THE CAGE WAS REMOVED AND REPLACED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93200 WAVE O CAGE INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX ADVANCED MEDICAL TECHNOLOGIES NA 12300F

    Patients

    Seq Age Sex Outcome Treatment
    1