BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 8423737 · Received March 15, 2019

    Report

    Report Number
    1030489-2019-00290
    Event Type
    Injury
    Date Received
    March 15, 2019
    Date of Event
    February 18, 2019
    Report Date
    March 15, 2019
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    MAX
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR SALE IN THE US BUT A SIMILAR PART WITH CATALOGUE# 9393008 AND 510K# K172199 AND UDI# (B)(4) IS APPROVED FOR SALE IN THE 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AT L3-L5 DUE TO STENOSIS. INTRA-OP, AFTER THE CAGE WAS INSERTED AT L3-L4 WITH INSERTER, AND WHEN THE INSERTER WAS REMOVED, IT WAS NOTICED THAT THE CAGE HAD COMPLETELY BACKED OUT FROM ITS POSITION IN THE FORWARD DIRECTION. THE BACKED OUT CAGE COULD NOT BE REMOVED. ONLY DUE TO THIS EVENT, POSTERIOR LUMBAR INTERBODY FUSION WAS ALSO PERFORMED AT L3-L4 USING 2 MORE CAGES. HENCE, IN TOTAL, THERE WERE 3 CAGES INSERTED AT L3-L4 (1 CAGE THAT BACKED OUT AND 2 NEW ONES). NO PROBLEM WAS OBSERVED AT L4-L5 AND TLIF WAS PERFORMED SUCCESSFULLY WITH ONLY ONE CAGE AT L4-L5. THERE WAS A DELAY OF MORE THAN 60 MINUTES IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. PATIENT COMPLICATIONS DUE TO THIS EVENT HAVE BEEN REPORTED AS UNKNOWN. NO REVISION SURGERY HAS BEEN PLANNED AT THIS POINT AND THE PATIENT IS UNDER FOLLOW-UP OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219091 CRESCENT SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MSD DEGGENDORF MFG NA 01FP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention