BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3039204 · Received April 5, 2013

    Report

    Report Number
    1030489-2013-00946
    Event Type
    Injury
    Date Received
    April 5, 2013
    Report Date
    May 28, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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).

    Additional Manufacturer Narrative · 1

    PER THE IMAGE REVIEW, THE FINDINGS ARE: (B)(6) 2014 ABDOMINAL ULTRASOUND NO SPINAL ANATOMY IMAGED. (B)(6) 2015 LUMBAR X-RAYS MULTIPLE FILMS ARE SHOWN OF THE LUMBAR SPINE. THE SPINE IS STRAIGHT WITHOUT SCOLIOSIS. A PEDICLE SCREW CONSTRUCT SITS AT L5/S1 WITH LAMINECTOMY BELOW L4. INTERBODY PEEK CRESCENT SPACER IS SEEN WITHIN THE L5 DISC SPACE. THE LATERAL VIEW IS UNDER PENETRATED AND DOES NOT SHOW THE CONSTRUCT CLEARLY. IT APPEARS THERE IS A SPINAL STIM GENERATOR, PAIN PUMP IN THE ABDOMINAL SUBCUTANEOUS TISSUE. ON (B)(6) 2015 LUMBAR MYELOGRAM MULTIPLE VIEWS OF CONSTRUCT AT L5/S1. NEEDLES ARE PRESENT AT THE L3 DISC SPACE INSERTING CONTRAST INTO THE DURAL SAC FOR MYELOGRAPHY. ONLY A FEW SHOTS ARE TAKEN AND THE AREA OF PREVIOUS SURGERY IS NOT ADEQUATELY IMAGED TO EVALUATE ROOT IMPINGEMENT POSTMYELOGRAM LUMBAR CT AXIAL IMAGES SHOW AN L5/S1 CONSTRUCT. THE L5 AND S1 SCREWS ARE BICORTICAL AND BILATERAL. ALL SCREWS ARE IN GOOD POSITION. CRESCENT SPACER WAS INSERTED FROM THE RIGHT AND IS IN GOOD POSITION. NO SIGNIFICANT HETEROTOPIC BONE IS VISUALIZED IN THIS STUDY. FACETECTOMY HAS BEEN PERFORMED ON THE RIGHT AT L5 CONSISTENT WITH A TLIF PROCEDURE AND THERE IS A SMALL AMOUNT OF BONE IN THE VICINITY OF THE PREVIOUS RIGHT L5/S1 FACET JOINT. NO STENOSIS IS NOTED. POSTOPERATIVE SCARING IS NOTED AROUND THE AREA WHERE THE SPACER WAS INSERTED AS IS TYPICAL AND UNAVOIDABLE. SAGITTAL AND CORONAL VIEWS VERIFY SOLID FUSION AT L5 WITHOUT FORAMINAL STENOSIS. CORONAL VIEWS ALSO SHOW APPARENTLY SOLID POSTEROLATERAL FUSION. ON (B)(6) 2015 BRAIN CT SKULL IS WELL SEEN. NO MIDLINE DEVIATIONS, FRACTURES OR TUMORS ARE NOTED. NO SIGN OF HEMATOMA. ONLY THE C1 ARCH AND ODONTOID ARE IMAGED AND APPEAR NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR APPROACH INTERBODY FUSION USING RHBMP-2/ACS AND A PEEK CAGE. THE PATIENT ALLE GEDLY NEVER RECOVERED FROM THE SURGERY, CONTINUES TO HAVE DAILY SEVERE DISABLING BACK AND NERVE PAIN, AND HAS HAD TO HAVE TWO SPINAL CORD STIMULATORS IMPLANTED ON TWO SEPARATE OCCASIONS. ADDITIONALLY, IT IS ALLEGED THAT THE "DRUG CAUSED BONE GROWTH IN THE SURGICAL SITE AROUND THE NERVES" IN THE SPINE RESULTING IN THE PATIENT'S INJURIES, INCLUDING NERVE COMPRESSION AND SEVERE, CHRONIC, AND ONGOING PAIN IN THE PATIENT'S BACK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH BILATERAL LEG PAIN AND FOLLOWING PRE-OP DIAGNOSES: ISTHMIC SPONDYLOLISTHESIS, L5 ON S1 WITH DEGENERATIVE DISK DISEASE. THE PATIENT UNDERWENT 1) POSTERIOR SPINAL FUSION L5-S1; 2) GILL LAMINECTOMY WITH FORAMINOTOMIES, L5 BILATERALLY; 3) TRANSFORAMINAL LUMBAR INTERBODY FUSION, L5-S1; 4) TITANIUM AND COBALT CHROME IMPLANTATION AT L5-S1; 5) IMPLANTATION OF PEEK INTERBODY CAGE SIZE 7X25 MM; AND 6) LOCAL BONE GRAFT WITH BMP GRAFTING. PER OP NOTES, DECORTICALIZATION WAS THEN DONE OF THE TRANSVERSE PROCESS IN THE SACRAL ALA BILATERALLY, AND BMP-SOAKED SPONGES ROLLED IN BURRITO FASHION WITH LOCAL BONE GRAFT WERE PLACED LATERAL ON THE TRANSVERSE PROCESS AND ALA. TWO COBALT CHROME RODS BENT IN LORDOSIS WERE CONNECTED WITH INNER PLUGS TO THE SCREWS AT L5 AND S1. A LITTLE DISTRACTION WAS DONE WITH A SCISSOR JACK AT L5-S1, IT WAS INCISED THEN A 7X25 MM IMPLANT WAS SELECTED. IT WAS FILLED WITH BMP SPONGES AND TAPPED IN ANTERIORLY BETWEEN L5-S1. MORE BONE GRAFT WAS PLACED DORSAL TO THE IMPLANT AND THEN TAPPED INTO PLACE. DISTRACTION WAS REMOVED AND COMPRESSION WAS DONE BETWEEN L5 AND S1, AND THE ANTETORSION DEVICE WAS USED TO SHEAR OFF THE HEX NUTS IN STANDARD FASHION FOR IMPLANTATION. X-RAYS WERE TAKEN, AP AND LATERAL, CONFIRMING ANATOMIC PLACEMENT OF SCREWS, RODS AND INTERBODY CAGES. THE PATIENT TOLERATED THE PROCEDURE WELL AND NO PATIENT COMPLICATIONS WERE NOTED. INTRA-OP, THE PATIENT UNDERWENT X-RAY OF LUMBAR SPINE DUE TO SPONDYLOTHESIS AT L5. (B)(6) 2010: THE PATIENT PRESENTED FOR A FOLLOW-UP VISIT STATUS POST L5 TLIF. IMPRESSION: DOING WELL. THE PATIENT ALSO UNDERWENT X-RAY OF SPINE WHICH SHOWED NO EVIDENCE OF COMPLICATIONS. (B)(6) 2010: THE PATIENT PRESENTED FOR AN OFFICE VISIT WITH COMPLAINT OF SEVERE PAIN IN THE BALL OF HER FOOT AND THE DORSUM OF HER FOOT AND TOES WITH HYPERSENSITIVITY. PATIENT HAD NO BACK PAIN AND NO LEFT LEG PAIN AT ALL, JUST A BURNING. PATIENT ALSO UNDERWENT X-RAY OF SPINE WHICH SHOWED EVERYTHING IN REASONABLE POSITION. (B)(6) 2010: THE PATIENT UNDERWENT CT SCAN OF LUMBAR SPINE WITHOUT CONTRAST DUE TO LOWER LIMB PAIN. IMPRESSION: INTERVAL INTERVERTEBRAL AND POSTERIOR SPINAL FUSION L5-S1. OSSEOUS FRAGMENTS FROM INTERVERTEBRAL ONE GRAFT EXTENDING INTO THE RIGHT LATERAL NEURAL FORAMEN WITH POTENTIAL FOR RIGHT L5 RADICULOPATHY. THE PATIENT ALSO UNDERWENT ELECTROMYOGRAPHY DUE TO RIGHT FOOT PAIN. IMPRESSION: EMG REVEALS NO ELECTROPHYSIOLOGIC EVIDENCE OF A RIGHT S1 RADICULOPATHY. THERE WAS NO SIGNIFICANT CHANGE FROM (B)(6) 2009. (B)(6) 2010: THE PATIENT PRESENTED FOR AN OFFICE VISIT WITH COMPLAINT OF HAVING PAIN IN THE DORSUM OF HER RIGHT FOOT TO THE MIDDLE THREE TOES. PATIENT ALSO UNDERWENT CT SCAN WHICH REVEALED, THERE WAS A VERY SMALL FAR LATERAL PIECE OF BONE GRAFT MATERIAL WHICH MAY BE IRRITATING PATIENT'S RIGHT L5 NERVE ROOT. (B)(6) 2010, (B)(6) 2010: THE PATIENT PRESENTED FOR A FOLLOW-UP VISIT. ASSESSMENT: BACK PAIN WITH RADIATION. (B)(6) 2010: THE PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSIS: RIGHT L5 RADICULOPATHY. FOR WHICH THE PATIENT UNDERWENT EXPLORATION AND REPEAT DECOMPRESSION WITH FORAMINOTOMIES AND OSTEOPHYTECTOMY AND SCAR EXCISION RIGHT L5. PER OP NOTES, NERVE ROOT RETRACTOR WAS ABLE TO IDENTIFY POSTERIOR BONE THAT HAD RETROPULSED FROM THE BONE GRAFT SIDE FROM THE T LIFT APPROACH. BONE GRAFT MATERIAL WHICH HAD MIGRATED POSTERIORLY WAS CAREFULLY IDENTIFIED. PITUITARY RONGEURS CLEANED OUT PIECES OF BONE GRAFT MATERIAL AND IMPLODED THE REMAINING BONE GRAFT MATERIAL ANTERIORLY INTO THE DISC SPACE THOROUGHLY. IT WAS DONE AT MULTIPLE SITES. THE PATIENT TOLERATED THE PROCEDURE WELL AND NO PATIENT COMPLICATIONS WERE NOTED. (B)(6) 2010: THE PATIENT PRESENTED FOR AN OFFICE VISIT WITH COMPLAINT OF STILL HAVING BACK PAIN DOWN RIGHT LEG. ASSESSMENT: BACK PAIN WITH RADIATION. IMPRESSION: CONTINUED RIGHT LOWER EXTREMITY RADICULAR SYMPTOMS DESPITE REPEAT DECOMPRESSION. (B)(6) 2010: THE PATIENT PRESENTED FOR AN OFFICE VISIT WITH COMPLAINT OF BILATERAL LOWER EXTREMITY RADICULAR SYMPTOMS STATUS POST EXPLORATION OF HER L5 NERVE ROOT. PATIENT WAS HAVING MORE PAIN IN HER RIGHT LEG AND STARTED TO HAVE SOME PAIN DOWN HER LEFT THIGH. IMPRESSION: LIKELY RECURRENT SCAR. (B)(6) 2010: THE PATIENT UNDERWENT MRI OF LUMBAR SPINE WITHOUT CONTRAST DUE TO LOWER LEG PAIN. IMPRESSIONS: 1. PATIENT UNABLE TO PERFORM POST CONTRAST IMAGING DUE TO PAIN. 2. NO INTERVAL CHANGE FROM APRIL WAS SEEN. 3. TISSUE IN THE RIGHT NEURAL FORAMEN AT L5-S1 LEVEL IS PROBABLY GRANULATION TISSUE, RATHER THAN DISC HERNIATION. 4. L4-L5 TINY CENTRAL DISC PROTRUSION WITHOUT IMPINGEMENT, UNCHANGED. (B)(6) 2010: THE PATIENT PRESENTED FOR A FOLLOW-UP VISIT WITH COMPLAINT OF RECURRENCE OF LEG PAIN ON THE RIGHT HAND SIDE. MRI SHOWED SOME SCAR TISSUE AROUND THE ROOT, BUT NO EVIDENCE OF NEUROLOGIC COMPROMISE. (B)(6) 2010: THE PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSES: 1) INTRACTABLE BACK PAIN, 2) FAILED BACK SYNDROME, 3) RIGHT GREATER THAN LEFT LOWER EXTREMITY PAIN, AND 4) STATUS POST TRIAL DORSAL COLUMN STIMULATOR. THE PATIENT UNDERWENT T10-T11 LAMINOTOMY AND IMPLANTATION OF A DORSAL COLUMN STIMULATOR LEAD ELECTRODE AND RIGHT ILIAC CREST IMPLANT OF RECHARGEABLE GENERATOR . THERE WERE NO COMPLICATIONS. THE PATIENT TOLERATED THE PROCEDURE WELL AND NO PATIENT COMPLICATIONS WERE NOTED. INTRA-OP, THE PATIENT UNDERWENT X-RAY OF THORACIC SPINE DUE TO FAILED BACK SYNDROME. (B)(6) 2011: THE PATIENT PRESENTED FOR AN OFFICE VISIT WITH COMPLAINT OF INCREASED LOW BACK PAIN AND LEG PAIN. PATIENT STATED THAT SHE HURT HER BACK WHILE SHOVELING AND HAS HAD LOW BACK AND LEFT-SIDED RADICULAR SYMPTOMS POSTERIORLY SINCE HER AGGRAVATION. ASSESSMENT: BACK PAIN WITH RADIATION. (B)(6) 2011: THE PATIENT UNDERWENT X-RAY OF LUMBAR SPINE WHICH SHOWED IMPLANTS AT L5-S1 IN GOOD POSITION WITH A SOLID POSTEROLATERAL ARTHRODESIS AND A WELL-POSITIONED TLIF CAGE. PATIENT HAD GOOD OVERALL ALIGNMENT AND A SPINAL CORD STIMULATOR WAS NOTED WITH CONTROL MODULE ON THE RIGHT. PATIENT ALSO HAD ACUTE LORDOSIS OF THE LUMBAR SPINE BUT LIMITED MOTION BETWEEN FLEXION AND EXTENSION. (B)(6) 2011: THE PATIENT UNDERWENT CT ANGIO HEAD AND NECK DUE TO NECK PAIN WITH NO KNOWN INJURY. IMPRESSIONS: 1. THE NONCONTRASTED HEAD CT AND THE HEAD CTA ARE LIMITED SECONDARY TO STREAK ARTIFACT FROM THE MULTIPLE ANEURYSM CLIPS. 2. WITHIN THE LIMITS OF THIS EXAMINATION, NEGATIVE HEAD CT FOR ACUTE ABNORMALITY. 3. NEGATIVE HEAD CTA FOR SIGNIFICANT FLOW-LIMITING STENOSIS OR NEW ANEURYSM FORMATION. 4. GREAT VESSELS OF THE NECK DEMONSTRATED NO SIGNIFICANT FLOW LIMITING STENOSIS OR ANEURYSM FORMATION. (B)(6) 2011: THE PATIENT PRESENTED FOR FOLLOW UP AND COMPLAINED OF BACK PAIN AND BILATERAL LEG PAIN. PATIENT WAS ORDERED FOR X-RAY. IMPRESSION: ACUTE EXACERBATION OF PAIN. ASSESSMENT: BACK PAIN WITH RADIATION; DISC DEGENERATION, LUMBAR; SPINAL STENOSIS, LUMBAR. (B)(6) 2011: THE PATIENT UNDERWENT X-RAY OF LUMBAR SPINE WHICH REVEALED A SOLID 5-1 ARTHRODESIS WITH INTERNAL SPINAL CORD STIMULATOR NOTED. LATERAL FLEXION AND EXTENSION SHOWED SOLID INTERBODY FUSION AND MILD EARLY DEGENERATION AT 4-5 ABOVE IT. (B)(6) 2011: THE PATIENT UNDERWENT CT OF LUMBAR SPINE WITHOUT CONTRAST DUE TO BACK PAIN WITH L2 SPINAL STENOSIS. IMPRESSIONS: 1. NORMAL POSTOPERATIVE CHANGE, WITH SOLID FUSION AT L5-S1. 2. MILD LATERAL RECESS STENOSIS BILATERALLY AT L4-L5, NOT APPRECIABLY CHANGED FROM (B)(6) 2010 BUT WITH INTERVAL IMPROVEMENT SINCE (B)(6) 2010. (B)(6) 2012: THE PATIENT PRESENTED WITH COMPLAINT OF CHRONIC BACK PAIN AND PAINFUL GENERATOR SITE. MUSCULOSKELETAL EXAMINATION REVEALED PATIENT WAS POSITIVE FOR BACK PAIN. (B)(6) 2012: THE PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSES: INTRACTABLE BACK PAIN, FAILED BACK SYNDROME, STATUS POST TRIAL DORSAL COLUMN STIMULATOR GENERATOR IMPLANT, PAINFUL GENERATOR SITE, MALFUNCTION GENERATOR, RECURRENT PAIN. FOR WHICH THE PATIENT UNDERWENT REVISION AND REPLACEMENT OF A DORSAL COLUMN STIMULATOR GENERATOR FROM POSTERIOR TO INTRA-ABDOMINAL AREA. PER OP NOTE, GENERATOR WAS MOBILIZED OUT OF SUBCUTANEOUS POCKET, GENERATOR WAS REMOVED. DISTAL LEADS WERE PASSED TO ABDOMINAL AREA AND CONNECTED TO NEW GENERATOR. THE PATIENT TOLERATED THE PROCEDURE WELL AND TRANSFERRED TO THE RECOVERY ROOM IN GOOD CONDITION. (B)(6) 2012: THE PATIENT PRESENTED FOR POST-OP CHECK. (B)(6) 2013: THE PATIENT UNDERWENT ULTRASOUND PELVIS TRANSVAGINAL DUE TO HISTORY OF PELVIC PAIN, TUBAL LITIGATION IN (B)(6), LMP IN (B)(6). IMPRESSION: 1. NORMAL EXAM. (B)(6) 2014: THE PATIENT UNDERWENT ULTRASOUND ABDOMEN LIMITED- RIGHT LOWER QUADRANT. IMPRESSION: 1. APPENDIX NOT VISUALIZED. MINIMAL FREE FLUID IN THE PELVIS. (B)(6) 2014: THE PATIENT PRESENTED FOR HER POST-OP VISIT FOLLOWING DIAGNOSTIC LAPAROSCOPY AND LAPAROSCOPIC APPENDECTOMY ON (B)(6) WITH COMPLAINT OF ABDOMINAL PAIN. (B)(6) 2015: THE PATIENT PRESENTED WITH THE FOLLOWING DIAGNOSES: FAILED BACK SURGICAL SYNDROME AND RIGHT LOWER QUADRANT PAIN. THE PATIENT UNDERWENT X-RAY OF LUMBAR SPINE DUE TO HISTORY OF LOWER BACK PAIN. IMPRESSION: 1. PREVIOUS LOWER LUMBAR LAMINECTOMY AND FUSION. 2. DEGENERATIVE DISC DISEASE L4-L5. 3. SPINAL CORD STIMULATOR AT T7 AND T8. (B)(6) 2015: THE PATIENT PRESENTED WITH THE FOLLOWING DIAGNOSES: FAILED BACK SURGICAL SYNDROME AND RIGHT LOWER QUADRANT PAIN. THE PATIENT UNDERWENT LUMBAR MYELOGRAM DUE TO HISTORY OF LOWER BACK PAIN, PREVIOUS SPINAL STIMULATOR PLACEMENT. IMPRESSION: LUMBAR PUNCTURE ACCESS FOR INJECTION OF CONTRAST FOR CT MYELOGRAM; POST-OP CHANGES FROM PREVIOUS L5-S1 POSTERIOR FIXATION WITH DECOMPRESSION. HARDWARE WAS GROSSLY INTACT. THE PATIENT ALSO UNDERWENT CT OF LUMBAR SPINE WITH CONTRAST- CT MYELOGRAM DUE TO HISTORY OF LOW BACK PAIN. IMPRESSION: 1. THE PATIENT IS STATUS POST POSTERIOR FUSION AT L5-S1. THERE WAS NO EVIDENCE OF HARDWARE FAILURE OR LOOSENING. CORTICAL SCREWS WERE ANCHORED WITHIN BONE. THERE WAS FUSION ACROSS THE L5-S1 DISC SPACE. 2. THERE WAS MILD RIGHT NEURAL FORAMINAL NARROWING AT L4-L5 AND L5-S1. (B)(6) 2015: THE PATIENT PRESENTED FOR A FOLLOW-UP VISIT. (B)(6) 2015: THE PATIENT UNDERWENT CT OF HEAD WITHOUT CONTRAST DUE TO INTERMITTENT HEADACHE FOR 2 DAYS. IMPRESSIONS: 1. ANEURYSM CLIPS AS BEFORE. 2. NO ACUTE INTRACRANIAL PROCESS EVIDENT. (B)(6) 2015: THE PATIENT PRESENTED WITH CHRONIC BACK PAIN. THE PATIENT WAS DIAGNOSED WITH FAILED BACK SURGICAL SYNDROME. ASSESSMENT: REVISION OF DCS GENERATOR SITE, WHICH WAS VERY PAINFUL TO TOUCH.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2013: PER THE BILLING RECORDS, THE PATIENT PRESENTED FOR PREVENTIVE VISIT AND HC THIN PREP PAP SCREENING. (B)(6) 2013: PER THE BILLING RECORDS, THE PATIENT PRESENTED FOR OFFICE OUTPATIENT VISIT. (B)(6) 2013: PER THE BILLING RECORDS, THE PATIENT PRESENTED FOR REMOVAL OF FALLOPIAN TUBE AND INTRAUTERINE DEVICE. (B)(6) 2013: PER THE BILLING RECORDS, THE PATIENT PRESENTED IN EMERGENCY DEPARTMENT AND UNDERWENT I&D PROCEDURE. (B)(6) 2013: PER THE BILLING RECORDS, THE PATIENT PRESENTED FOR OFFICE OUTPATIENT VISIT AND UNDERWENT FOLLOWING PROCEDURE: CULTURE OTHER SOURCE, HERPES SIMPLEX VIRUS CULTURE, CHLAMYDIA AMPLIFIED DNA PROBE, NEISSERIA GONORRHOEAE AMP DNA (B)(6) 2014: PER THE BILLING RECORDS, THE PATIENT PRESENTED FOR PREVENTIVE VISIT. (B)(6) 2014, (B)(6) 2014, (B)(6) 2014: PER THE BILLING RECORDS, THE PATIENT UNDERWENT VARIOUS LAB PROCEDURES. (B)(6) 2014, (B)(6) 2014: PER THE BILLING RECORDS, THE PATIENT PRESENTED FOR OUTPATIENT VISIT TO HOSPITAL. (B)(6) 2008 PATIENT PRESENTS FOR EVALUATION OF A WOUND ON HER LEFT HEEL. DIAGNOSIS: ABRASION LEFT HEEL. (B)(6) 2010 CT SCAN REVEALED A BILATERAL L5 SPONDYLOSIS WITHOUT SPONDYLOLISTHESIS AND A SMALL RIGHT SIDED AND CENTRAL DISC PROTRUSION AT L5-S1 AND L4-L5 ALSO. (B)(6) 2010 PATIENT FOLLOWED-UP ON POST-OP DAY 1. PATIENT WAS DOING WELL AND COMPLAINED OF BACK PAIN. (B)(6) 2010 PATIENT DISCHARGED TO HOME. (B)(6) 2010 PATIENT PRESENTED WITH RIGHT LOWER EXTREMITY RADICULOPATHY. CT SCAN REVEALED A VERY SMALL FAR LATERAL PIECE OF BONE GRAFT MATERIAL WHICH MAY BE IRRITATING THE RIGHT L5 NERVE ROOT (B)(6) 2010 PATIENT DISCHARGED TO HOME. (B)(6) 2010 PATIENT PRESENTED WITH BACK PAIN. (B)(6) 2010 PATIENT PRESENTED FOR LOW SPINE AND SACROILIAC EVALUATION. PATIENT ABLE TO AMBULATE LEVEL SURFACES WITH A MINIMAL DEVIATION. PATIENT STILL IN RIGHT LEG AND RIGHT LOWER BACK AFTER SURGERY. X-RAY, MRI AND CT SCANS WERE DONE. (B)(6) 2010 PATIENT PRESENTED FOR AN OFFICE VISIT WITH A COMPLAINT OF LEG PAIN. ASSESSMENT: LUMBOSACRAL NEURITIS/RADICULITIES. (B)(6) 2010 ASSESSMENT: THERAPY DIAGNOSIS: LUMBOSACRAL NEURITIS/RADICULITIES. (B)(6) 2010 PATIENT PRESENTED WITH LOW BACK PAIN. POST-OPERATIVE MRI SHOWS A FUSION AT L5-S1. NO APPARENT PROBLEMS. DIAGNOSIS: INTRACTABLE BACK PAIN; FAILED BACK SYNDROME; RIGHT LOWER EXTREMITY PAIN; RADICULOPATHY; STATUS POST TRIAL OF A DORSAL COLUMN STIMULATOR. (B)(6) 2010 PATIENT PROGRAMMER, ANTENNA, CHARGING SYSTEM, AND ACCESSARY KITS WERE USED. (B)(6) 2010 PATIENT PRESENTED WITH FAILED BACK SYNDROME. (B)(6) 2011: PATIENT PRESENTED WITH A COMPLAINT OF HEADACHE. (B)(6) 2011: PATIENT PRESENTED WITH COMPLAINT OF GENERATOR PAIN. (B)(6) 2013: PER THE BILLING RECORDS, THE PATIENT PRESENTED FOR REMOVAL OF FALLOPIAN TUBE AND INTRAUTERINE DEVICE. PATIENT PRESENTED WITH PRE-OP DIAGNOSIS OF UNDESIRED FERTILITY AND POST-OPERATIVE DIAGNOSIS OF UNDESIRED FERTILITY AND SALPINGITIS. PATIENT UNDERWENT OPERATIVE LAPAROSCOPY, BILATERAL TUBAL LIGATION WITH CAUTERY AND BILATERAL SALPINGECTOMY. (B)(6) 2013 PATIENT PRESENTED WITH PRE-OP DIAGNOSIS OF MULTIPLE DECAYED AND FRACTURED TEETH. PATIENT UNDERWENT SURGICAL EXTRACTION OF TEETH NUMBERS 1,16,17, 32,18, 24 AND 31. ON (B)(6) 2014 THE PATIENT PRESENTED WITH A PRE-OP DIAGNOSIS OF RIGHT LOWER QUADRANT PAIN AND UNDERWENT DIAGNOSTIC LAPAROSCOPY AND LAPAROSCOPIC APPENDECTOMY GENERAL. FINDINGS: NORMAL APPENDIX; NO INTRA-ABDOMINAL PATHOLOGY TO EXPLAIN THE PAIN. THE PATIENT PRESENTED WITH COMPLAINTS OF ABDOMINAL PAIN WITH NAUSEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140191 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110806AAJ

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR Required Intervention