BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 7908179 · Received September 25, 2018

    Report

    Report Number
    1030489-2018-01280
    Event Type
    Malfunction
    Date Received
    September 25, 2018
    Date of Event
    September 3, 2018
    Report Date
    September 25, 2018
    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 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

    PRE-OPERATIVE DIAGNOSIS: KYPHOSCOLIOSIS PROCEDURE: TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) LEVELS IMPLANTED: T11-L5 IT WAS REPORTED THAT INTRA-OP, THE INTER VERTEBRAL DISC SPACE WAS SO NARROW THAT WHEN INSERTING CAGE INTO POSTERIOR INTERBODY WHICH WAS WITH SPUR AND THE EARLY STAGE OF HAMMERING, THE CAGE WAS BROKEN. NO FRAGMENT OF THE IMPLANT OR INSTRUMENT REMAINING IN THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745983 CRESCENT SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MSD DEGGENDORF MFG NA 01DX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other