BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSTONE® SPINAL SYSTEM

    MDR report key: 2860903 · Received December 6, 2012

    Report

    Report Number
    1030489-2012-02616
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    MAX
    PMA / PMN Number
    K073291
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    MEDICAL INTERPRETATION: X-RAY OF LUMBAR SPINE AFTERL5/S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF). REASON FOR SURGERY IS OBSCURE AS SEVERE DEGENERATIVE DISC DISEASE IS PRESENT AT L3/4, L4/5, AND L5/S1. FUSION NOTED AT LS/2 LEAVING ONLY L1/2 AS A FUNCTIONING (NORMAL DISC). VACUUM DISC PHENOMENON NOTED AT L3/4, L4/5. END PLATE REMODELING AND DEVELOPING FUSION NOTED THROUGH SPACER AS EXPECTED. NO "EROSION" OR MALFUNCTION IS APPARENT. CONTINUED ARTHRITIC BACK PAIN WOULD BE AN EXPECTED OUTCOME IN THE PATIENT. INCONCLUSIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "EROSION" OF BOTH CRANIAL AND CAUDAL ENDPLATES OF THE TREATED DISK OCCURRED. BONE UNION DID NOT OCCUR.

    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 H11J2111

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Other