BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSTONE SPINAL SYSTEM

    MDR report key: 2103204 · Received May 25, 2011

    Report

    Report Number
    1030489-2011-00620
    Event Type
    Injury
    Date Received
    May 25, 2011
    Report Date
    April 26, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    MAX
    PMA / PMN Number
    K073291
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. THE LOTS THAT WERE IMPLANTED ARE H09L6623, EXPIRATION DATE 12/07/2017; H10B3286, EXPIRATION DATE 03/10/2018; AND H10B3289, EXPIRATION DATE 03/30/2018. THE MANUFACTURE DATE FOR LOT H09L6623 IS 12/07/2009; THE MANUFACTURE DATE FOR LOT H10B3286 IS 03/10/2010; THE MANUFACTURE DATE FOR LOT H10B3289 IS 03/30/2010. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    VISUAL AND OPTICAL EXAMINATION OF RETURNED IMPLANT DID NOT REVEAL ANY FRACTURE, CRACK OR BREAKAGE. PLASTIC DEFORMATION NOTED ON ONE SIDE OF RETENTION FEATURES, CONSISTENT WITH IMPLANTATION. DIMENSIONAL EVALUATION OF IMPLANT DID CONFIRM PRODUCT CONFORMANCE TO OVERALL SIZE DIMENSIONS. VISUAL COMPARISON OF IMPLANT TO SAMPLE PRODUCT DID NOT IDENTIFY IMPLANT GEOMETRY DIFFERENCE, EXCEPT AS PREVIOUSLY NOTED. UNABLE TO DETERMINE ROOT CAUSE OF EVENT, BASED ON THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PLIF PROCEDURE AT L3/4 AND L4/5 IMPLANTED INTERBODY DEVICES. ONE OF THE CAGES AT L4/5 WAS BACKED OUT POST OP. THE PATIENT COMPLAINED OF PAIN. REPORTEDLY, THE POST OP EXCESSIVE MOVEMENT MAY HAVE CAUSED THE INCIDENT. THE REVISION SURGERY WAS PERFORMED APPROXIMATELY FOUR MONTHS POST OP. THE BACKED OUT DEVICE WAS REMOVED. REPORTEDLY THE PATIENT IS GETTING WELL AFTER THE REVISION SURGERY.

    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 H10B3289

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Required Intervention