BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 8062095 · Received November 12, 2018

    Report

    Report Number
    1030489-2018-01469
    Event Type
    Injury
    Date Received
    November 12, 2018
    Report Date
    February 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 USE IN THE US, HOWEVER A LIKE DEVICE WITH PART# 9393013, 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE PEEK CAGE WAS RETURNED IN SEVERAL PIECES. MICROSCOPIC ANALYSIS SHOWS THAT THE CAGE FAILED FROM MATERIAL OVERLOAD. THE ANGLE AND DIRECTION OF THE BREAK ARE CONSISTENT WITH BEND STRESS OVERLOAD. IT APPEARS THE DIRECTION OF THE FORCE MAY HAVE SHIFTED OFF ACCESS ON THE CAGE LEADING TO THE FAILURE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    AS PER IMAGE REVIEW " PART OF MRI, XRAY AND SINGLE CT RECONSTRUCTED IMAGE PROVIDED FOR L5-S1, TLIF. THE CAGE APPEARS TO BE SUBSIDED INTO THE VERTEBRAL BODY AND WAS FRACTURED BY REPORT. THIS IS OFTEN THE RESULT OF DISRUPTING THE VERTEBRAL ENDPLATE WHEN PLACING THE GRAFT. AS FUSION HAS NOT OCCURRED A REVISION SURGERY WAS PERFORMED BY REPORT.". IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PROCEDURE AND TECHNIQUE: MINIMALLY INVASIVE SPINAL TRANSFORAMINAL LUMBAR INTERBODY FUSION PRE-OPERATIVE DIAGNOSIS: NEUROLOGICAL SYMPTOM IT WAS REPORTED THAT POST-OP, IN THE X-RAY IMAGES TAKEN ABOUT 3 MONTHS LATER AFTER SURGERY, THE APPEARANCE OF THE MARKER LOOKED OBVIOUSLY STRANGE, AND IT WAS IMAGED THAT THE CAGE WAS PROBABLY BROKEN. REVISION SURGERY WAS PERFORMED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901294 CRESCENT SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MSD DEGGENDORF MFG NA 84CA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention