BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 8221137 · Received January 7, 2019

    Report

    Report Number
    1030489-2019-00013
    Event Type
    Malfunction
    Date Received
    January 7, 2019
    Date of Event
    December 7, 2018
    Report Date
    January 7, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 9393007, 510K #K172199 AND 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 WAS PRE-OPERATIVELY DIAGNOSED WITH L4/5 LCS (LUMBAR CANAL STENOSIS) AND UNDERWENT TLIF (TRANSFORAMINAL LUMBAR INTERBODY FUSION) SURGERY. DURING SURGERY, THE CAGE BROKE DURING HAMMERING. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENTS OF THE IMPLANT ARE REMAINING IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF ALLEGED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14424 CRESCENT SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MSD DEGGENDORF MFG NA 98FJ

    Patients

    Seq Age Sex Outcome Treatment
    1