BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 6629016 · Received June 9, 2017

    Report

    Report Number
    1030489-2017-01479
    Event Type
    Injury
    Date Received
    June 9, 2017
    Report Date
    May 15, 2017
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NEK
    UDI-DI
    00681490843805
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    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. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. 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.

    Additional Manufacturer Narrative · 1

    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 PRESENTED WITH FOLLOWING PRE-OPERATIVE DIAGNOSIS: SEVERE DEGENERATIVE DISC DISEASE, L5-S1 WITH CHRONIC LOW BACK PAIN. FOR WHICH HE UNDERWENT FOLLOWING PROCEDURES: LUMBAR LAMINECTOMY, FORAMINOTOMY, DISCECTOMY L4-S1 WITH DECOMPRESSION BILATERALLY OF THE L4 AND S1 NERVE ROOTS. POSTERIOR LUMBAR INTERBODY FUSION. INSERTION OF 9MM SPINAL USA PEEK CAGES L5-S1. POSTERIOR INTER-TRANSVERSE FUSION, L5-S1. NON-SEGMENTAL PEDICLE SCREW INSTRUMENTATION, L5-S1 USING SPINAL USA. 5X40MM POLYAXIAL TITANIUM SCREWS. USE OF LOCAL BONE GRAFT FOR SPINE FUSION, AUGMENTED WITH 30 CC OF CANCELLOUS ALLOGRAFT, MEDIUM RHBMP-2. AS PER OP- NOTES ¿30CC OF CANCELLOUS ALLOGRAFT HAD BEEN SOAKED IN ANTIBIOTIC SOLUTION. THIS WAS COMBINED WITH A MEDIUM RHBMP-2/ACS KIT THAT HAD BEEN MORCELLIZED ALONG WITH THE REMAINDER OF THE LOCAL BONE GRAFT. FURTHERMORE, 1.5GM OF VANCOMYCIN POWDER WAS MIXED IN WITH THIS AND THIS MIXTURE PLACED IN EQUALLY DIVIDED AMOUNTS IN THE L5-S1 INTER-TRANSVERSE REGION BILATERALLY.¿ PATIENT TOLERATED THE OVERALL PROCEDURE WITHOUT ANY COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412300 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK NA M110908AAO 00681490843805

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other