BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 11544385 · Received March 22, 2021

    Report

    Report Number
    1030489-2021-00382
    Event Type
    Malfunction
    Date Received
    March 22, 2021
    Date of Event
    March 1, 2021
    Report Date
    March 22, 2021
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    MAX
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 9393009, 510K #K172199 AND UDI# (B)(4) WAS CLEARED IN THE UNITED STATES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH LUMBAR DEGENERATIVE STENOSIS FOR SPINAL THERAPY. IT WAS REPORTED THAT WHILE IMPLANTING THE DEVICE USING THE IMPACTOR, A PIECE OF THE IMPLANT BROKE OFF. IT WAS RETRIEVED. THE REMAINDER WAS LEFT IN THE PATIENT AS IT WAS DETERMINED TO BE IN AN ACCEPTABLE POSITION AND IT WOULD BE TOO DIFFICULT TO EXPLANT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THERE WAS NO TIME DELAY REPORTED DUE TO THE RETRIEVAL OF BROKEN PART. THERE WAS NO REVISION SURGERY PLANNED TO EXPLANT THE IMPLANTED DEVICE. THE PROCEDURE INVOLVED WAS A FUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435708 CRESCENT SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MSD DEGGENDORF MFG 9393009INT 68KF

    Patients

    Seq Age Sex Outcome Treatment
    1