BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 6248745 · Received January 13, 2017

    Report

    Report Number
    1030489-2017-00091
    Event Type
    Malfunction
    Date Received
    January 13, 2017
    Date of Event
    December 19, 2016
    Report Date
    December 19, 2016
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    MAX
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR PRODUCT WITH CATALOG# 9393610, UDI # (B)(4) AND 510K# K094025 IS AVAILABLE FOR SALE IN US. THE PRODUCT IS NOT RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WITH DEGENERATIVE DISC DISEASE TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L5/S1. INTRA-OP, THE CAGE BROK E WHEN THE PHYSICIAN TRIED TO RELOCATE IT. THE CT SCAN CONFIRMED THE LOCATION OF THE BROKEN PART. THE PART OF THE CAGE THAT BROKE REMAINED CONNECTED TO THE EXPLANTATION INSTRUMENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31947 CRESCENT SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MSD DEGGENDORF MFG NA 61AL

    Patients

    Seq Age Sex Outcome Treatment
    1