BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSTONE SPINAL SYSTEM

    MDR report key: 8642915 · Received May 25, 2019

    Report

    Report Number
    1030489-2019-00579
    Event Type
    Malfunction
    Date Received
    May 25, 2019
    Date of Event
    April 25, 2019
    Report Date
    August 14, 2019
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    MAX
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: VISUAL AND OPTICAL EXAMINATION REVIEW CONFIRMS IMPLANT FRACTURE. WITNESS MARKS AND MATERIAL DEFORMATION NOTED ON THE THROUGH HOLE OF THE PEEK ANTERIOR RAMP. THESE OBSERVATIONS ARE CONSISTENT WITH OVERLOAD OF THE IMPLANT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A SIMILAR DEVICE WITH CATALOG # 2990832, 510K #K073291 AND UDI # (B)(4) WAS CLEARED IN THE UNITED STATES. PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L4-L5 DUE TO L4-L5 GRADE 1 DEGENERATIVE SPONDY. INTRA-OP, IT WAS NOTICED THAT THE DEVICE WAS NOT IN ALIGNMENT WITH THE INSERTER AND THE PHYSICIAN INDICATED THAT THE DEVICE HAD BROKEN. ACCORDING TO THE PHYSICIAN, THE CAGE MAY NOT HAVE BEEN PROPERLY ATTACHED TO THE INSERTER. THE BROKEN DEVICE WAS IMMEDIATELY REMOVED AND REPLACED WITH ANOTHER ONE OF THE SAME SIZE, WITHOUT ANY PROBLEM. NO FRAGMENT OF THE BROKEN DEVICE REMAINED INSIDE THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF ALLEGED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436386 CAPSTONE SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MDT SOFAMOR DANEK PUERTO RICO MFG NA H5079031

    Patients

    Seq Age Sex Outcome Treatment
    1