BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGENIX PLUS

    MDR report key: 1933233 · Received December 20, 2010

    Report

    Report Number
    1030489-2010-01610
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    October 12, 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

    THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. HOWEVER, THE SUSPECT DEVICES IN USE ARE LOT# 1409090048, LOT# 1409090046, LOT# 1409090037, AND LOT# 1409090042. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON CONFORMANCE TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A HISTORY OF BACK RADICULAR SYMPTOMS AND FAILED CONSERVATIVE MEASURES OF RECURRENT L2-S1 SPONDYLOLISTHESIS AND STENOSIS. THE PATIENT UNDERWENT A REDO OF L1-S1 LAMINECTOMIES WITH L2 THRU S1 BILATERAL OSTEOTOMIES AND DISKECTOMIES WITH INTERBODY FUSIONS WITH PEEK CAGES WITH AUTOGRAFT, ALLOGRAFT AND BMP AS WELL AS L2-S1 PEDICLE SCREW FUSION WITH AUTOGRAFT, ALLOGRAFT BONE AND BMP WITH REDUCTION IN SPONDYLOLISTHESIS WITH INTRAOPERATIVE MICROSCOPY, FLUOROSCOPY, AND IMPLANTATION OF 2 INTRAMUSCULAR PAIN PUMPS THRU 2 SEPARATE STAB INCISIONS. PER THE OPERATIVE NOTES, THIS WAS AN EXTRA EFFORT CASE SECONDARY TO MORBIDLY OBESE PATIENT (B)(6) WITH SIGNIFICANT INCREASE IN TIME AND EXPOSURE AND DEFINITIVE PROCEDURE. AN UNKNOWN TIME POST-OP, THE PATIENT DEVELOPED AN INFECTION. REVISION SURGERY IS TBD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention RHBMP-2/ACS, CAPSTONE PEEK, POSTERIOR FIXATION