BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 2239888 · Received September 8, 2011

    Report

    Report Number
    1030489-2011-01138
    Event Type
    Injury
    Date Received
    September 8, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 15, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH
    Product Code
    MAX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) IS NOT APPROVED FOR USE IN THE US, HOWEVER, A LIKE DEVICE, 9393008, 510K# K094025, IS APPROVED FOR USE. THE DEVICE HAS NOT BEEN RETURNED TO MEDTRONIC FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO DOCUMENTATION TO INDICATE A NON-CONFORMANCE TO SPECIFICATION. UNABLE TO DETERMINE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A TLIF AT L3-L4-L5 WITH PEEK INTERBODY DEVICE. WHILE IMPACTING THE SECOND CAGE A L4-L5 THE CAGE BROKE INTO TWO PIECES. THE SMALLER PIECE WAS REMOVED BUT THE OTHER COULD NOT BE RETRIEVED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRESCENT SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH UE07

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Other