BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSTONE PTC SPINAL SYSTEM

    MDR report key: 10243459 · Received July 8, 2020

    Report

    Report Number
    1030489-2020-00848
    Event Type
    Malfunction
    Date Received
    July 8, 2020
    Date of Event
    June 12, 2020
    Report Date
    July 8, 2020
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    MAX
    PMA / PMN Number
    SEE H10
    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# 3992608, 510K# K172199, 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) SURGERY AT 1LEVEL DUE TO LUMBAR DEGENERATIVE CASE. INTRA-OP, THE BACK-SIDE OF THE IMPLANT BROKE DURING THE OPERATION. THE FRAGMENT WAS EXPLANTED BUT THE MAIN PART OF THE IMPLANT STAYS IN THE PATIENT. NO PATIENT INJURY WAS REPORTED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707358 CAPSTONE PTC SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MDT SOFAMOR DANEK PUERTO RICO MFG NA H5539561

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR