BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSTONE SPINAL SYSTEM

    MDR report key: 3129766 · Received May 24, 2013

    Report

    Report Number
    1030489-2013-01884
    Event Type
    Injury
    Date Received
    May 24, 2013
    Report Date
    May 16, 2013
    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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): A REVIEW OF RADIOGRAPHIC IMAGES SHOW 3 LATERAL VIEWS OF LUMBAR SPINE. IMAGE 1 SHOWS PRE-OP DEGENERATIVE L4 DISC WITH MINIMAL SPONDY. IMAGE 2 SHOWS PEDICLE SCREW CONSTRUCT WITH NO INTERBODY DEVICE SEEN. ONE L4 SCREW APPEARS TO HAVE PULLED OUT AND IS THUS MALPOSITIONED IN PEDICLE AND ONLY 35-40% INTO BODY. IMAGE 3 SHOWS REVISION WITH CLEAR INTERBODY DEVICE, SCREWS OD APPROPRIATE LENGTH AND POSITION.

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 2991236, PRODUCT CODE MAX WAS CLEARED IN THE UNITED STATES. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 2991236, 510K # K073291 WAS CLEARED IN THE UNITED STATES. A REVIEW OF RADIOGRAPHIC IMAGES SHOW INITIAL THREE VIEWS ARE AN AP, LATERAL OF THE LUMBAR SPINE AND A FULL LATERAL BODY VIEW. THE PATIENT HAS TWO TOTAL HIP REPLACEMENTS WHICH APPEAR WELL SEATED. THE LUMBAR SPINE IS VERY ARTHRITIC WITH A DEGENERATIVE SPONDYLOLISTHESIS AT L4/5 AND ABUNDANT ANTERIOR OSTEOPHYTES. ANKYLOSIS APPEARS TO BE PRESENT AT MULTIPLE LEVELS. THE BODY VIEW DOES NOT ADD. SECOND THREE FILMS SHOW A TLIF HAS BEEN PERFORMED AT L4/5. THE CAPSTONE IS ONLY 50% WITHIN THE DISC SPACE AND PROTRUDES POSTERIORLY. SCREW POSITION APPEARS SATISFACTORY AND THE SLIP HAS BEEN PARTIALLY REDUCED. SEBSEQUENT THREE FILMS ARE UNCHANGED FROM THE MIDDLE SET. AS NO CHANGE IS SEEN BETWEEN THE MIDDLE AND BOTTOM SET, NO POSTOPERATIVE FAILURE CAN BE DETERMINED OTHER THAN THE SPACER IS NOT PROPERLY POSITIONED. THE TIMING OF THIS IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE, AT AN UNKNOWN TIME POST-OP, IT WAS NOTED THAT A SCREW HAD BACKED OUT. A REVISION WAS DONE TO REPLACE THE SCREW. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232414 CAPSTONE SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1