BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 8066875 · Received November 13, 2018

    Report

    Report Number
    1030489-2018-01475
    Event Type
    Malfunction
    Date Received
    November 13, 2018
    Date of Event
    October 19, 2018
    Report Date
    November 13, 2018
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    MAX
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 9393011, 510K #K172199, UPN#(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

    PRE-OPERATIVE DIAGNOSIS: DEGENERATIVE DISK DISEASE PROCEDURE: MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION LEVEL IMPLANTED: L5-S1 IT WAS REPORTED THAT INTRA-OP, SPACER BROKE INTO MULTIPLE PIECES DURING IMPACTION. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT REMAINS IN THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATION WERE REPORTED AS RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906594 CRESCENT SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MSD DEGGENDORF MFG NA 95DN

    Patients

    Seq Age Sex Outcome Treatment
    1