BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3070966 · Received April 22, 2013

    Report

    Report Number
    1030489-2013-01181
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    April 16, 2018
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. 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)(4) (PSEUDOARTHROSIS), (B)(4) (LEG PAIN). 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

    (B)(4)

    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 SUSTAINED UNSPECIFIED INJURIES FOLLOWING THE USE OF RHBMP-2/ACS IN AN UNSPECIFIED SPINAL FUSION SUR GERY. NO ADDITIONAL INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2010: THE PATIENT PRESENTED WITH L4-L5 SPONDYLOSIS AND UNDERWENT THE FOLLOWING PROCEDURES: LEFT L4-L5 TRANSFORAMINAL LUMBAR INTERBODY FUSION; BILATERAL L4-L5 FORAMINOTOMY WITH MEDIAL FACECTOMY; BILATERAL L4 AND L5 PEDICLE SCREW FUSION. AS PER-OP NOTES, ¿ THE DISC SPACE L4-L5 WAS ISOLATED AND ANNULOTOMY WAS PERFORMED. A 10 * 28 LEOPARD INTER-BODY SPACER WAS PACKED WITH BMP. THIS WAS INSERTED THROUGH THE LEFT HAND SIDE AS THE PATIENT¿S SYMPTOMS ARE ALL ON THE LEFT.¿ ON (B)(6) 2011: THE PATIENT UNDERWENT CT OF LUMBAR SPINE WITHOUT CONTRAST. THE RESULTS WERE COMPARED WITH THE MRI OF LUMBAR SPINE OF (B)(6) 2011. IMPRESSION: OPERATIVE CHANGES COMPATIBLE WITH POSTEROLATERAL SCREW FIXATION AT L4-L5 WITH PARTIAL DISCECTOMY AND INTER-VERTEBRAL PROSTHESIS PRESENT. LESION WITHIN THE LEFT SUB-ARTICULAR RECESS IS NOTED BETTER CHARACTERIZED ON MRI LUMBAR SPINE PERFORMED THE SAME DAY. DIFFERENTIAL CONSIDERATIONS INCLUDE SMALL FLUID COLLECTION OR DISC EXTRUSION. CORRELATION WITH NEUROSURGICAL EVALUATION WOULD BE HELPFUL; BILATERAL L4-L5 FRAGMENTED APPEARING FACETS AND MILD PREISCREW LUCENCIES. THIS MAY BE RELATED TO POST OPERATIVE CHANGE, HOWEVER CORRELATION WITH HISTORY AS WELL AS EVIDENCE OF LOOSENING OR LESS LIKELY INFECTION AS THERE IS NO ASSOCIATED INFLAMMATORY CHANGE. ON (B)(6) 2011: THE PATIENT PRESENTED WITH LEFT L4-5 RESOLVING HAMATOMA AND UNDERWENT THE FOLLOWING PROCEDURES: RE-EXPLORATION OF PREVIOUS L4-5 TLIF INCISION WITH EVALUATION OF CHRONIC HEMATOMA; EXPLORATION OF FUSION; EXPLORATION OF LEFT L4 AND L5 NERVE ROOTS. ON (B)(6) 2011: THE PATIENT UNDERWENT MRI OF LUMBAR SPINE DUE TO L4 NERVE ROOT HEMATOMA PREVIOUSLY, NEW LEFT LEG WEAKNESS/PAIN. CONTRAST MEDIA: GADOLINIUM. THE RESULTS WERE COMPARED WITH THOSE OBTAINED ON (B)(6) 2011. IMPRESSION: OPERATIVE CHANGES IN L4-L5. THE PREVIOUSLY NOTED LEFT FORAMINAL FLUID COLLECTION IS NOT PRESENT AND PRESUMABLY HAS BEEN RESECTED. THERE IS ENHANCING NON-SPECIFIC SOFT TISSUE IN THE LEFT NEURAL FORAMEN WHICH MAY REPRESENT SCAR OR GRANULATION TISSUE. ON (B)(6) 2012: THE PATIENT UNDERWENT MRI OF LUMBAR SPINE. THE RESULTS WERE COMPARED WITH THOSE OBTAINED ON (B)(6) 2011. IMPRESSION: OPERATIVE CHANGES AT L4-L5 ARE AGAIN NOTED. THERE IS MILD ENCROACHMENT ON THE LEFT SUB-ARTICULAR RECESS AND LEFT NEURAL FORAMEN WITHIN THE CONFINES OF FIELD DISTORTION ARTIFACT. THERE IS NO SEVERE CENTRAL CANAL COMPROMISE OR ABNORMAL INTRA-CANALICULAR ENHANCEMENT OF THE LUMBAR SPINE. ON (B)(6) 2012: THE PATIENT UNDERWENT CT OF LUMBAR SPINE WITHOUT CONTRAST. THE RESULTS WERE COMPARED WITH THOSE OBTAINED ON (B)(6) 2011 AND MRI OF (B)(6) 2012. IMPRESSION: AGAIN DEMONSTRATED ARE OPERATIVE CHANGES COMPATIBLE POSTERIOR FIXATION AT L4-L5 WITH AN INTER-VERTEBRAL PROSTHESIS IN PLACE. THERE IS NEW PRESUMED OSSEOUS BRIDGING ALONG THE POSTERIOR DISC SPACE ON THE LEFT; THERE HAS BEEN INTERVAL PLACEMENT OF A METALLIC LEAD WITHIN THE POSTERIOR SPINAL CANAL ENTERING AT THE L1-L2 LEVEL. THE SUPERIOR MOST ASPECT OF THE METALLIC LEAD IS EXCLUDED FROM THE FIELD VIEW; FRAGMENTATION OF THE FACETS AT L4-L5 AGAIN DEMONSTRATED; THERE IS NO SIGNIFICANT SPINAL CANAL STENOSIS. ON (B)(6) 2013: THE PATIENT UNDERWENT CT OF LUMBAR SPINE WITHOUT CONTRAST. THE RESULTS WERE COMPARED WITH THOSE OBTAINED ON (B)(6) 2012. IMPRESSION: UNCHANGED POST-OPERATIVE APPEARANCE OF THE LUMBAR SPINE. NO ACUTE FINDINGS. ON (B)(6) 2013: THE PATIENT PRESENTED WITH L4-5 PSEUDOARTHROSIS AND ADJACENT SEGMENT DEGENERATIVE DISC DISEASE AFTER PREVIOUS L4-5 FUSION. THE PATIENT UNDERWENT REVISION L3-S1 MINIMALLY TRANSFORAMINAL LUMBAR INTER-BODY FUSION UTILIZING PEDICLE SCREW INSTRUMENTATION SYSTEM, INTERBODY SPACER, LOCAL AUTOGRAFT AND NOVABONE BONE EXTENDER. ON (B)(6) 2015: THE PATIENT UNDERWENT MRI OF LUMBAR SPINE DUE TO INDICATION OF POST-LAMINECTOMY AND LUMBAR RADICULOPATHY (HAS TITANIUM RODS). LIMITED IMAGES OF SOFT TISSUE STRUCTURES IN THE RETRO-PERITONEUM DEMONSTRATE NO ABNORMALITIES. ON (B)(6) 2015: THE PATIENT UNDERWENT X-RAY OF LUMBAR SPINE POST LAMINECTOMY. NO RADIOGRAPHIC FINDINGS OF ACUTE COMPLICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010, THE PATIENT UNDERWENT HIS SPINE FUSION SURGERY (FROM A TRANSFORAMINAL AND POSTEROLATERAL APPROACH) ON THE LUMBAR REGION OF HIS SPINE FROM VERTEBRAE L4 TO L5, WITH THE HELP OF RHBMP-2 AND COLLAGEN SPONGE. IT WAS REPORTED THAT THE RHBMP-2 COLLAGEN SPONGE WAS PLACED OUTSIDE A CAGE (I.E. IN THE LATERAL GUTTERS). POST-OP, THE PATIENT COMPLAINED OF PROGRESSIVELY WORSENING PAIN IN HIS LOW BACK, WITH ASSOCIATED PAIN AND RADICULOPATHY IN HIS LOWER EXTREMITIES. IT WAS REPORTED THAT DUE TO THESE SEVERE SYMPTOMS THE PATIENT UNDERWENT REVISION SURGERY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED BOWEL INCONTINENCE AND SEXUAL DYSFUNCTION AND COULD NOT STAND OR WALK FOR EXTENDED PERIODS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172850 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC M110812AAD

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other| R