BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 7141503 · Received December 22, 2017

    Report

    Report Number
    1030489-2017-02544
    Event Type
    Malfunction
    Date Received
    December 22, 2017
    Date of Event
    November 29, 2017
    Report Date
    April 27, 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

    PTHIS PART IS NOT APPROVED FOR USE IN THE US, HOWEVER A LIKE DEVICE WITH PART# 9392507, 510K# K172199 AND UPN (B)(4) IS AVAILABLE FOR THE MARKET. PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE R EPORTED EVENT.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: VISUAL AND MICROSCOPIC EXAMINATION SHOWED THAT THE IMPLANT HAS BROKEN NEAR THE LOCATION WHERE IT INTERFACES WITH THE INSERTER. THE SHAPE AND RAYS OF THE FRACTURE FACE ARE CONSISTENT WITH TORSIONAL OVERLOAD. 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 PREOPERATIVELY DIAGNOSED WITH L3 BURST FRACTURE, STENOSIS AND UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L2/3. DURING THE SURGERY, THE CAGE WAS BROKEN DURING INSERTION. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENTS REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS THE RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922009 CRESCENT SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MSD DEGGENDORF MFG NA 31BV

    Patients

    Seq Age Sex Outcome Treatment
    1