BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 8193520 · Received December 24, 2018

    Report

    Report Number
    1030489-2018-01695
    Event Type
    Malfunction
    Date Received
    December 24, 2018
    Date of Event
    November 29, 2018
    Report Date
    December 24, 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

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 9392507 , 510K #K172199 AND UDI # (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 SPONDYLOLISTHESIS OCCURRED AT L4; SPINAL CANAL STENOSIS OCCURRED AT L4-5. PROCEDURE USED: TRANSFORAMINAL LUMBAR INTERBODY FUSION (L4-5) IT WAS REPORTED THAT INTRA-OP, THE CAGE BROKE WHILE ROTATING INSIDE THE VERTEBRAL BODY AND IMAGE OF MARKER WAS NOT IN POSITION. THE BROKEN CAGE WAS REMAINED IN THE PATIENT'S BODY. THERE WAS LESS THAN 60 MIN DELAY IN OVERALL PROCEDURE TIME AS A RESULT OF THE EVENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1032831 CRESCENT SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MSD DEGGENDORF MFG NA 12DS

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR