BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGENIX DBM PUTTY

    MDR report key: 1933449 · Received December 20, 2010

    Report

    Report Number
    1030489-2010-01613
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 22, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    MBP
    PMA / PMN Number
    K081950
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIFICATION OR DEVIATIONS IN PROCEDURE WHICH MIGHT CONTRIBUTE TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH RECURRENT T12-L5 SPONDYLOLISTHESIS AND STENOSIS. THE PATIENT UNDERWENT A REDO OF PRIOR T12-L5 LAMINECTOMIES, L1-L5 BILATERAL OSTEOTOMOIES AND DISCECTOMIES AND INTERBODY FUSIONS. AN UNKNOWN TIME POST-OP, THE PATIENT WAS DIAGNOSED WITH A WOUND INFECTION AND UNDERWENT AN ASPIRATION AND LAMINECTOMY FROM L1-L5 WITH WOUND ABCESS IN SUBCUTANEOUS AND SUBMUSCULAR WITH USE OF INTRAOPERATIVE FLUOROSCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGENIX DBM PUTTY FILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR) MBP MEDTRONIC SOFAMOR DANEK USA, INC NA 1409090051

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention RHBMP-2/ACS, CAPSTONE PEEK, POSTERIOR FIXATION