BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 2269753 · Received September 29, 2011

    Report

    Report Number
    1030489-2011-01236
    Event Type
    Injury
    Date Received
    September 29, 2011
    Date of Event
    September 1, 2011
    Report Date
    September 1, 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). REVISION SURGERY. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 9393007, 510K # K094025, WAS CLEARED IN THE UNITED STATES. THE DEVICE HAS NOT BEEN RETURNED TO MEDTRONIC FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO INFORMATION TO INDICATE A NON-CONFORMANCE TO SPECIFICATION. UNABLE TO DETERMINE CAUSE OF THE EVENT.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO TREAT STENOSIS WITH IMPLANT OF PEEK INTERBODY DEVICE VIA TLIF AT L4-5. REPORTEDLY THE CAGE WAS BROKEN DURING INSERTION. THE BROKEN CAGE WAS REMOVED AND ANOTHER WAS IMPLANTED. THE PATIENT UNDERWENT A SECOND PROCEDURE A WEEK LATER DUE TO SUSPECTED HEMATOMA, HOWEVER IT WAS DETERMINED NO HEMATOMA WAS OBSERVED. THE SURGEON SHAVED BONE AND REMOVED SMALL AMOUNT OF BONE GRAFT TO DECOMPRESS THE ROOT.

    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 TV40

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention