BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 8442816 · Received March 22, 2019

    Report

    Report Number
    1030489-2019-00309
    Event Type
    Malfunction
    Date Received
    March 22, 2019
    Date of Event
    February 28, 2019
    Report Date
    March 22, 2019
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    MAX
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG# 9392507, 510K # K172199 AND UDI (B)(4) IS APPROVED FOR SALE IN US. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF 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 LUMBAR CANAL STENOSIS AND SPONDYLO LISTHESIS. INTRA-OP, THE CAGE BROKE INTO TWO PIECES NEAR THE ENTRANCE OF THE INTERVERTEBRAL DISC SPACE DURING INSERTION. THE BROKEN PIECES WERE TAKEN OUT WITH A TWEEZER AND NO FRAGMENT OF BROKEN CAGE REMAINED IN THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238817 CRESCENT SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MSD DEGGENDORF MFG NA 01DX

    Patients

    Seq Age Sex Outcome Treatment
    1