BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 4853513 · Received June 18, 2015

    Report

    Report Number
    1030489-2015-01222
    Event Type
    Injury
    Date Received
    June 18, 2015
    Report Date
    May 19, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING STUDIES RETURNED TO MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    PATIENT PRESENTED POST SPINAL FUSION INDICATING A PSEUDOARTHROSIS WITH A PERSISTENT BACK AND LEG PAIN. X-RAYS AND CT SCANS INDICATED PSEUDOARTHROSIS OF PRIOR FUSION. PRIOR TO REVISION, PATIENT FAILED CONSERVATIVE TREATMENT. PRE-OP DIAGNOSES: 1. DEGENERATIVE DISC DISEASE L3-S1. 2. STATUS POST SPINAL FUSION AND INSTRUMENTATION FROM L3-S1 LEVEL. PATIENT UNDERWENT FOLLOWING PROCEDURES: 1. REMOVAL OF HARDWARE WITH EXPLORATION OF FUSION MASS AT THE L3-L4, L4-L5 AND L5-S1 LEVEL. 2. SUBSEQUENT RE-GRAFTING AND RE-FUSION AT THE L3-4 LEVEL AND L5-S1 LEVEL UTILIZING RHBMP-2/ACS BONE MORPHOGENIC PROTEIN FOR THE POSTERIOR FUSION PART OF THE PROCEDURE WITH UN-INSTRUMENTED FUSION. PER OP NOTES, CONTINUOUS RUNNING EMGS AS WELL AS SSEPS WERE MONITORED THROUGHOUT THE PROCEDURE. THE TRANSVERSE PROCESSES AT L3 AND ON DOWN TO L4 AND THEN L5-S1 WAS DECORTICATED. LOCAL ALLOGRAFT SUPPLEMENTED WITH RHBMP-2/ACS SOAKED SPONGE WRAPPED AROUND GRAFT WAS IMPACTED IN THE POSTEROLATERAL REGION AT L3-4 LEVEL AND L5-S1 LEVEL FOR THE POSTERIOR FUSION PART OF THE PROCEDURE. NO COMPLICATIONS REPORTED. POST-OP DIAGNOSES: 1. DEGENERATIVE DISC DISEASE L3-S1. 2. STATUS POST SPINAL FUSION AND INSTRUMENTATION FROM L3-S1 LEVEL. 3. PSEUDOARTHROSIS AT THE L3-4 AND L5-S1 LEVEL. GROSS FINDINGS: PSEUDOARTHROSIS L3-4 AND L5-S1 LEVEL WITH SUBSEQUENT REPEAT UN-INSTRUMENTED POSTEROLATERAL FUSION WITH SOME MILD PERINEURAL SCARRING FROM THE L3-S1 LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398571 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other