BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 6796533 · Received August 16, 2017

    Report

    Report Number
    1030489-2017-01914
    Event Type
    Injury
    Date Received
    August 16, 2017
    Date of Event
    July 19, 2017
    Report Date
    July 19, 2017
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    MAX
    PMA / PMN Number
    SEE H10
    Adverse Event
    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# 9393009 AND 510K# K094025 AND (B)(4) IS APPROVED FOR SALE IN THE US. 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 THE PATIENT PRESENTED WITH THE PRE-OPERATIVE DIAGNOSIS OF SPONDYLOLISTHESIS AT L6/S1, AND UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION FROM LEFT SIDE. INTRA-OP, THE INSERTED CAGE WAS FOUND TO BE POSITIONED OUTSIDE THE INTERVERTEBRAL DISC SPACE. ATTEMPTS WERE MADE TO REMOVE THIS CAGE BUT THE CAGE COULD NOT BE REMOVED. AS A RESULT, THE SURGEON HAD TO PERFORM POSTERIOR LUMBAR INTERBODY FUSION AS WELL, APPROACHING FROM BOTH SIDES, AND HE INSERTED TWO MORE CAGES ONE BY ONE FROM BOTH THE SIDES. THE PROCEDURE WAS DELAYED BY MORE THAN 60 MINUTES DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577387 CRESCENT SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MSD DEGGENDORF MFG NA 14BX

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other