BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGENIX DBM PUTTY

    MDR report key: 1933443 · Received December 20, 2010

    Report

    Report Number
    1030489-2010-01611
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    September 15, 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# 1385400076, LOT# 138540079, AND LOT# 138540075. 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.

    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# 1385400073, 1385400076, LOT# 138540079, AND LOT# 138540075.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A PROGRESSIVE DEFORMITY WITH KYPHOSIS, SPINAL INSTABILITY, INCREASE OF LEFT LUMBAR LORDOSIS, L1 COMPRESSION FRACTURE AND LOOSENING OF THE SCREWS AT L1. THE PATIENT UNDERWENT REDO OF A PRIOR L2-S1 FUSION PLUS T9-S1 POSTERIOR INSTRUMENTATION, REMOVAL OF L1 PEDICLES SCREWS, REVISION OF INTERBODY FUSION L1-L2 WITH REVISION OF THE L1-L2 CAGE AND L1 KYPHOPLASTY. AN UNKNOWN TIME POST-OP, THE PATIENT WAS DIAGNOSED WITH A SUPERFICIAL WOUND INFECTION. THE INFECTION WAS INITIALLY MANAGED WITH INFECTIOUS DISEASE WITH ANTIBIOTICS AND DRESSING CHANGES. THE PATIENT WAS THEN ADMITTED TO NURSING HOME AND RETURNING WITH A WORSENING WOUND WITH 3 POINTS OF LEAKAGE OF SEROPURULENT MATERIAL. THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE NECROTIC TISSUES. THERE WERE FOUR POINTS BREAKING ON THE SKIN WITH LEAKAGE OF SEROPURULENT MATERIAL. THE SKIN WAS OPENED WITH GOOD BORDERS OF THIS NECROTIC TISSUE UNTIL WE WENT INTO THE FASCIA. IN THE FASCIA, IT WAS NOTED THAT THERE WAS WORSENING OF THE NECROTIC TISSUE. OPENED ALL THE FASCIA, REMOVED ALL THE NECROTIC TISSUE FROM THE MUSCLES, AND THE SUBCUTANEOUS TISSUE WITH A KNIFE AND WITH CURETTES AND USED 6 LITERS OF SALINE WITH BACITRACIN.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Required Intervention