BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 6688844 · Received July 6, 2017

    Report

    Report Number
    1030489-2017-01682
    Event Type
    Injury
    Date Received
    July 6, 2017
    Report Date
    June 7, 2017
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    MAX
    PMA / PMN Number
    REFER 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 SALE IN THE US BUT A SIMILAR PART WITH CATALOGUE# 9392511 AND 510K# K094025 AND UDI# (B)(4) IS APPROVED FOR SALE IN THE US. (B)(4) 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2014, PATIENT UNDERWENT AN UNKNOWN SURGERY. POST-OP, CAGE BACK-OUT WAS OBSERVED. RECURRENCE OF STENOSIS HAS ALSO BEEN REPORTED. HENCE, A REVISION SURGERY, POSTERIOR LUMBAR INTERBODY FUSION(PLIF) AT L4-5 WAS PERFORMED ON (B)(6) 2017 TO EXPLANT THE PRODUCTS. NO PATIENT COMPLICATIONS WERE REPORTED AFTER THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470711 CRESCENT SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MSD DEGGENDORF MFG NA XC25

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention