BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 5078953 · Received September 15, 2015

    Report

    Report Number
    1030489-2015-02367
    Event Type
    Injury
    Date Received
    September 15, 2015
    Report Date
    August 17, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2006 THE PATIENT UNDERWENT SURGERY. PREOPERATIVE DIAGNOSIS: LUMBAR HERNIATED DISK WITH BACK PAIN AND LEG PAIN. PROCEDURES PERFORMED: 1. ANTERIOR LUMBAR DISKECTOMY WITH DECOMPRESSION, REMOVAL OF FREE FRAGMENT DISK, FORAMINOTOMY, TAKEDOWN OF PLL AND DECOMPRESSION, L5-S1 LEVEL. 2. ANTERIOR LUMBAR INTERBODY FUSION L5-S1. 3. USE OF CAGES X 2 L5-S1. 4. USE OF ANTERIOR LUMBAR PLATE L5-S1. 5. USE OF BONE MORPHOGENIC PROTEIN. PEROP NOTES: REAMING WAS PERFORMED, CURETTAGE, FUSION WAS PERFORMED AND PREPARATION OF THE ENDPLATES. THE DISK WAS STABILIZED WITH THE CAGES, BMP WAS USED FOR THE FUSION. WE USED THE 18 X 23 AND THIS WAS FELT COULD BE PLACED INTO THE MIDLINE. WITH GOOD POSITIONING ON X-RAY USING THE DOUBLE-TANG INSERTER. WE PERFORMED A COMPLETE DISKECTOMY. BACK TO THE POSTERIOR-LATERAL COMERS. WE TOOK DOWN THE PLL. WE REMOVED A CENTRAL PIECE AND REMOVED A FREE FRAGMENT PIECE ON THE RIGHT SIDE. PERFORMING A DECOMPRESSION TAKING DOWN THE PLL WITH AN ADEQUATE DECOMPRESSION. THOROUGH ANTIBIOTIC IRRIGATION WAS USED. WE CHECKED THE RETROPERITONEAL STRUCTURES AND FOUND NO INJURY. THE CAGES WERE STUFFED WITH BMP. ONE MEDIUM KIT WITH 2 SPONGES IN EACH CAGE. A PLATE WAS THEN CHOSEN. ONE SCREW WAS PLACED INTO L5 AND 2 SCREWS INTO S1. WE EXPOSED THE LIP OF THE PERIOSTEUM WITH SHARP DISSECTION. ON (B)(6) 2007 THE PATIENT WAS PRESENTED FOR OFFICE VISIT WITH BACK PAIN AND LEG PAIN. MUSCULOSKELETAL EXAMINATION: HE COMPLAINED OF PAIN PRIMARILY ON THE RIGHT AND ALSO IT SEEMED TO BE EXACERBATED WITH ROTATION TO THE RIGHT AND LOADING THE FACETS ON THE RIGHT AS WELL. ON (B)(6) 2007 THE PATIENT UNDERWENT CT SCAN OF LUMBAR SPINE. IMPRESSIONS: SUCCESSFUL LUMBAR MYELOGRAM PROCEDURE. POST-OPERATIVE CHAN GES ARE IDENTIFIED AT THE LUMBOSACRAL JUNCTION AND A TRANSITIONAL VERTEBRAE NOTED AT THE LUMBOSACRAL JUNCTION AS WELL. ON (B)(6) 2007 THE PATIENT WAS PRESENTED FOR OFFICE VISIT WITH RIGHT LEG PAIN. CONCLUSION: THIS WAS A NORMAL STUDY WITH NO ELECTROPHYSIOLOGIC EVIDENCE OF RADICULOPATHY, PLEXOPATHY, POLYNEUROPATHY OR MYOPATHY SEEN. ON (B)(6) 2007 THE PATIENT WAS PRESENTED FOR OFFICE VISIT. MUSCULOSKELETAL EXAMINATIONS REVIEW: LUMBAR RANGE OF MOTION IS LIMITED. RIGHT AND LEFT LUMBOSACRAL TENDERNESS. NEUROLOGICAL : CNN IS GROSSLY INTACT. IMPRESSIONS: 1. THE PATIENT IS STATUS POST ALIF (B)(6) 2006. 2. POST-OP CHANGED. NO OTHER SPINE THERAPY. 3. FACET DISEASE. ON (B)(6) 2007 THE PATIENT WAS PRESENTED FOR OFFICE VISIT. THE PATIENT ALSO UNDERWENT X-RAYS OF THE RIGHT WRIST. NO COMPLICATION WAS REPORTED. IMPRESSIONS: 1. RIGHT CARPAL TUNNEL SYNDROME WITH POSSIBILITY OF SOME EARLY DOUBLE CRUSH. 2. RIGHT SHOULDER IMPINGEMENT. ON (B)(6) 2008 THE PATIENT WAS PRESENTED FOR OFFICE VISIT WITH PAIN AND SWELLING IN HIS RIGHT KNEE. ON EXAMINATIONS IT WAS OBSERVED THAT HAD MILD PREPATELLAR BURSITIS OF HIS KNEE. HE ALSO UNDERWENT X-RAYS OF KNEE. NO COMPLICATION WAS REPORTED. IMPRESSIONS: PREPATELLAR BURSITIS, RIGHT KNEE. ON (B)(6) 2008 THE PATIENT WAS PRESENTED FOR OFFICE VISIT WITH LEFT ELBOW SWELLING. ON EXAMINATIONS AN OBVIOUS OLECRANON BURSITIS, WHICH IS TENDER. THE PATIENT UNDERWENT X-RAYS OF ELBOW. NEGATIVE FOR ACUTE BONY ABNORMALITY. IMPRESSION: OLECRANON BURSITIS, LEFT ELBOW. ON (B)(6) 2009 THE PATIENT UNDERWENT MRI OF LUMBAR SPINE. IMPRESSIONS: REMOTE POSTOPERATIVE CHANGES OF THE LUMBAR SPINE AT L5-S1 WITH ANTERIOR LUMBAR DISCECTOMY AND FUSION. NO EVIDENCE OF ADHESIVE ARACHNOIDITIS AND NO SIGNIFICANT POSTOPERATIVE GRANULATION TISSUE ALONG THE THECAL SAC OR NERVE ROOTS AT THE LEVEL OF L5-S1. ON (B)(6) 2010 THE PATIENT WAS PRESENTED FOR OFFICE VISIT FOR FOLLOW UP ON TIGHT CARPAL TUNNEL RELEASE. NO COMPLICATION WAS REPORTED. ON (B)(6) 2010 THE PATIENT UNDERWENT A SURGERY. PREOPERATIVE DIAGNOSIS: RIGHT CARPAL TUNNEL SYNDROME. PROCEDURE PERFORMED: RIGHT CARPAL TUNNEL RELEASE. ON (B)(6) 2010 THE PATIENT WAS PRESENTED FOR OFFICE VISIT FOR FOLLOW UP ON TIGHT CARPAL TUNNEL RELEASE. NO COMPLICATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610333 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