BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSTONE PTC SPINAL SYSTEM

    MDR report key: 9956379 · Received April 14, 2020

    Report

    Report Number
    1030489-2020-00452
    Event Type
    Injury
    Date Received
    April 14, 2020
    Report Date
    April 14, 2020
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    MAX
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 3993210, 510K # K172199 AND UDI # (B)(4) WAS CLEARED IN THE UNITED STATES. 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. 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 (TLIF) AT L3-L4. IN THIS SURGERY, A CAGE WAS IMPLANTED WITH 4MG OF RHBMP-2/ACS IN IT. ON AN UNKNOWN DATE, POST-OP, THE CAGE MIGRATED OUTSIDE INTERLUMBAR SPACE. HENCE, ON (B)(6) 2020, AN ADDITIONAL TLIF WAS PERFORMED AT THE SAME LEVEL WITH A NEW CAGE AND WITHOUT RHBMP-2/ACS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422521 CAPSTONE PTC SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MDT SOFAMOR DANEK PUERTO RICO MFG NA H5551339

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention