BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 6700070 · Received July 11, 2017

    Report

    Report Number
    1030489-2017-01727
    Event Type
    Malfunction
    Date Received
    July 11, 2017
    Date of Event
    June 13, 2017
    Report Date
    June 13, 2017
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    MAX
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE US, HOWEVER A LIKE DEVICE WITH PART# 9393608, 510K# K094025 AND UPN (B)(4) HAS BEEN CLEARED FOR US. 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.

    Description of Event or Problem · 1

    TYPE OF PROCEDURE USED: TRANSFORAMINAL LUMBAR INTERBODY FUSION(TLIF) IT WAS REPORTED THAT DURING SURGERY, THE CAGE BROKE UPON INSERTION. THE BROKEN PART OF THE CAGE COULD NOT BE RETRIEVED COMPLETELY AS IT GOT STUCK INSIDE THE VERTEBRAL BODY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481932 CRESCENT SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MSD DEGGENDORF MFG NA 29BT

    Patients

    Seq Age Sex Outcome Treatment
    1