BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3965116 · Received July 29, 2014

    Report

    Report Number
    1030489-2014-03347
    Event Type
    Injury
    Date Received
    July 29, 2014
    Report Date
    July 7, 2014
    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)(4). 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.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4).

    Description of Event or Problem · 1

    PER MEDICAL RECORDS, IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT LUMBAR FUSION SURGERY. POST OPERATIVELY, A CT SCAN CONFIRMED PSEUDOARTHROSIS. THERE WAS NO EVIDENCE OF A SOLID FUSION IN THE POSTEROLATERAL GUTTERS AND THERE WAS A FIBROUS NON UNION. (B)(6) 2011 THE PATIENT PRESENTED WITH THE FOLLOWING PRE OP DIAGNOSES: 1. LUMBAR PSEUDOARTHROSIS 2. TOBACCO ABUSE. 3. LUMBAR SPONDYLOSIS. 4. LUMBAR RADICULITIS. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: 1. REMOVAL OF SEGMENTAL HARDWARE L4-S1. 2. EXPLORATION AND FUSION WITH DOCUMENTATION OF PSEUDOARTHROSIS L4 TO THE SACRUM. 3. FACET FUSION L4-L5 AND L5-51 BILATERALLY UTILIZING PRE-MACHINED BONE DOWELS. 4. POSTEROLATERAL FUSION UTILIZING AUTOLOGOUS ILIAC CREST BONE GRAFT HARVESTED FROM THE LEFT, PLUS RHBMP-2/ACS. 5. USE OF A ALLOGRAFT BONE FOR RECONSTITUTION OF GRAFT. 6. USE OF NEURAL MONITORING. 7. USE OF C-ARM. PER THE OP NOTES, THE BONE GRAFT WAS MIXED WITH RHBMP-2/ACS. THIS WAS PLACED IN THE POSTEROLATERAL DECORTICATED RECESSES OF L4 TO THE SACRUM BILATERALLY FOLLOWING IRRIGATION. THERE WERE NO INTRAOPERATIVE COMPLICATIONS OR SURGICAL COMPLICATIONS NOTED. NEURAL MONITORING WAS PERFECT THROUGHOUT. FINAL AP AND LATERAL RADIOGRAPHS WERE ANATOMIC.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED UNSPECIFIED INJURIES FOLLOWING THE USE OF RHBMP-2/ACS IN AN UNSPECIFIED SPINAL FUSION SURGERY. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441356 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other