BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSTONE SPINAL SYSTEM

    MDR report key: 1941251 · Received December 29, 2010

    Report

    Report Number
    1030489-2010-01657
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 6, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    MAX
    PMA / PMN Number
    K073291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MACROSCOPIC EXAMINATION CONFIRMS IMPLANT IS BROKEN AT THE INSERTER INTERFACE TAB. MICROSCOPIC EXAMINATION OF THE FRACTURE SURFACE REVEALS A BRITTLE FRACTURE WITH NO INDICATION OF FATIGUE. THE DIRECTION AND ANGULATION OF THE FRACTURE, IN ADDITION TO THE NEARLY SYMMETRICAL CRACK ON THE OPPOSITE SIDE OF THE INSERTER INTERFACE FEATURE SUGGESTS A TORSIONAL OVERLOAD AS THE MECHANISM OF FAILURE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT 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 PEEK IMPLANT BROKE WITH THE SECOND STRIKE FROM THE MALLET. THE BROKEN PIECES WERE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSTONE SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS NA H09D4459

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR