BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSTONE SPINAL SYSTEM

    MDR report key: 2072688 · Received April 29, 2011

    Report

    Report Number
    1030489-2011-00469
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    March 28, 2011
    Report Date
    April 1, 2011
    Manufacturer
    MSD BARTLETT MFG
    Product Code
    MAX
    PMA / PMN Number
    K073291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. VISUAL EXAMINATION CONFIRMS THE SUPERIOR TANG IS BROKEN; THE BROKEN PIECE IS MISSING, AND NOT RETURNED FOR ANALYSIS. MICROSCOPIC EXAMINATION OF THE FRACTURE SURFACE REVEALS A FAIRLY QUASI-BRITTLE FRACTURE WITH NO INDICATION OF FATIGUE. FRACTURE INITIATION APPEARS TO BE LOCATED AT THE BASE OF THE TANG, CONSISTENT WITH BEND STRESS OVERLOAD. A REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO INFORMATION TO INDICATE A NON-CONFORMANCE TO SPECIFICATION.

    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 WHILE INSERTING THE CAGE, THE INSERTER BROKE. THE INSERTER AND BROKEN PIECE WERE REMOVED FROM THE PATIENT. ALTHOUGH THIS OCCURRED DURING SURGERY, 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 MSD BARTLETT MFG MA07L070

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR