INFUSE BONE GRAFT
Report
- Report Number
- 1030489-2014-03028
- Event Type
- Injury
- Date Received
- July 7, 2014
- Report Date
- September 28, 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
(B)(4).
(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.
IT WAS REPORTED THAT ON (B)(6) 2006 MRI OF THE LUMBAR SPINE INDICATED ¿SMALL CENTRAL T12-L1 DISK HERNIATION. GRADE 1 SPONDYLOLISTHESIS OF L5 ON S1 WITHOUT SIGNIFICANT CENTRAL CANAL OR NEURAL FORAMINAL STENOSIS PRESENT.¿ ON (B)(6) 2006 MRI OF THE CERVICAL SPINE INDICATED ¿CERVICAL SPONDYLOSIS WITH DISC OR HERNIATIONS.¿ ON (B)(6) 2008 MRI OF THE LUMBAR SPINE INDICATED ¿SEVERE DEGENERATIVE DISC AND ENDPLATE CHANGES AT L5-S1 LEVEL AND SEVERE BILATERAL FACET ARTHROPATHY, RESULTING IN GRADE 1 ANTEROLISTHESIS. NO SPINAL CANAL STENOSIS. MODERATE STENOSIS OF THE LEFT NEURAL FORAMEN, WITH POSSIBLE COMPRESSION OF THE EXITING LEFT L5 NERVE ROOT. MILD DEGENERATIVE DISC AND FACET JOINT CHANGES AT OTHER LUMBAR LEVELS AS DESCRIBED.¿ ON (B)(6) 2008, PATIENT PRESENTED FOR CONSULT WITH COMPLAINTS OF NECK PAIN, BILATERAL ARM PAIN, BACK PAIN, AND BILATERAL LEG PAIN. PATIENT WAS DIAGNOSED WITH SPONDYLOLISTHESIS AT L5-S1, SEVERE DEGENERATIVE DISC DISEASE L5-S1, AND MODIC ENDPLATE CHANGES L5-S1. ON (B)(6) 2008 THE PATIENT PRESENTED WITH DEGENERATIVE DISC DISEASE AT L5-S1 AND SPONDYLOLISTHESIS AT L4-5-S1. PATIENT UNDERWENT LUMBAR LAMINECTOMY, PLIF L4-S1, AND PLF L3-S1 USING K2M INTERBODY CAGES, RHBMP-2/ACS, BIOMET PEDICLE SCREW INSTRUMENTATION, ALLOGRAFT, AND LOCAL AUTOGRAFT. THERE WERE NO NOTED COMPLICATIONS. ON 5/21/2008 THE PATIENT PRESENTED FOR POST-OP FOLLOW UP. X-RAYS INDICATED ¿FUSION FROM L3 TO S1. THE HARDWARE WAS IN GOOD ALIGNMENT. THERE WAS NO COMPLICATING PROCESS NOTED.¿ ON (B)(6) 2008, THE PATIENT PRESENTED FOR FOLLOW UP. X-RAYS INDICATED ¿THE LEFT L3 SCREW TO BE LOOSE FROM THE VERTEBRAL BODY. THE INTERBODY CAGE WAS UNCHANGED FROM THE PREVIOUS EXAMINATION.¿ ON (B)(6) 2008, THE PATIENT PRESENTED WITH COMPLAINTS OF RIGHT SIDED BACK PAIN AS WELL AS RIGHT-SIDED BUTTOCK PAIN. REVIEW OF X-RAYS WERE UNCHANGED FROM THE PREVIOUS STUDY. ON (B)(6) 2009 PATIENT PRESENTED TO THE ER WITH COMPLAINTS OF DIARRHEA AND COLICKY PAIN IN THE PARIETAL AREA MORE ON THE LEFT. PATIENT WAS DIAGNOSED WITH GASTROENTERITIS AND WAS DISCHARGED. ON (B)(6) 2010 PATIENT PRESENTED FOR FOLLOW UP WITH COMPLAINTS OF NECK AND BACK PAIN. ¿THE PATIENT USED A WALKER FOR AMBULATION. THE PATIENT HAD BILATERAL TRAPEZIUS SPASMS. EXAMINATION OF THE CERVICAL SPINE SHOWED A NORMAL POSTURE. THERE WAS NO LOCAL TENDERNESS. THE RANGE OF MOTION WAS NORMAL¿ THERE WAS NO OBVIOUS WASTING ON THE UPPER EXTREMITIES.¿ ON (B)(6) 2010 PATIENT PRESENTED FOR FOLLOW UP WITH COMPLAINTS OF NECK PAIN AND BILATERAL ARM PAIN AS WELL AS LOW BACK PAIN. ON (B)(6) 2010 PATIENT PRESENTED WITH ARTHRITIS OF THE RIGHT KNEE, AND UNDERWENT A KNEE REPLACEMENT. ON (B)(6) 2011 PATIENT PRESENTED WITH COMPLAINTS OF NECK PAIN AS WELL AS NUMBNESS IN THE RIGHT HAND. X-RAYS INDICATED ¿LOSS OF LORDOSIS. THERE WAS A 1 MM ANTEROLISTHESIS OF C4 ON C5 ON FLEXION. THERE WAS DEGENERATIVE DISC DISEASE, MOST SIGNIFICANT AT C56¿ SCOLIOSIS WITH AN APEX AT L23 ABOVE THE PREVIOUS FUSION. THERE WAS NO EVIDENCE OF HARDWARE LOOSENING.¿ ON (B)(6) 2011 PATIENT PRESENTED TO THE ER WITH ABDOMINAL PAIN, NAUSEA, VOMITING, AND COMPLAINTS OF ¿GOING THROUGH WITHDRAWAL.¿ PATIENT WAS HYDRATED AND WAS DISCHARGED HOME WITH PRESCRIPTION FOR REGLAM. DISCHARGE DIAGNOSES: ABDOMINAL PAIN, NAUSEA, VOMITING, PROBABLE NARCOTIC WITHDRAWAL. ON (B)(6) 2012 PATIENT PRESENTED FOR FOLLOW UP WITH COMPLAINTS OF RIGHT-SIDED BACK PAIN AND BUTTOCK PAIN. REVIEW OF A CT SCAN OF THE L UMBAR SPINE INDICATED ¿SOLID FUSION. THE RIGHT L3 SCREW DOES APPEAR TO BE WITHIN THE PSOAS MUSCLE.¿ REVISION SURGERY WAS DISCUSSED. ON (B)(6) 2012 MRI OF THE CERVICAL SPINE INDICATED ¿AT THE C5-C6 LEVEL, DISK OSTEOPHYTE COMPLEX ABUTS THE ANTERIOR ASPECT OF THE SPINAL CORD CREATING MILD CENTRAL SPINAL CANAL STENOSIS.¿ ON (B)(6) 2012 PATIENT PRESENTED WITH COMPLAINTS OF RIGHT-SIDED BACK AND BUTTOCK PAIN. REVIEW OF MRI DATED (B)(6) 2012 INDICATED ¿CENTRAL DISC HERNIATION AT C45 AND C56. THERE WAS A SMALL CENTRAL DISC HERNIATION AT C34. THERE WAS DEGENERATIVE DISC DISEASE OF THE CERVICAL SPINE.¿ REVIEW OF CT SCAN OF THE LUMBAR SPINE DATED (B)(6) 2012 INDICATED ¿A SOLID FUSION. THE RIGHT L3 SCREW THAT APPEARED TO BE WITHIN THE PSOAS MUSCLE.¿ ON (B)(6) 2012 PATIENT PRESENTED FOR PRE-OP EVALUATION. PATIENT REPORTS LOW ENERGY LEVELS, ANGINA, NECK PAIN, ARM PAIN/WEAKNESS/NUMBNESS, BACK PAIN, LEG PAIN/WEAKNESS/NUMBNESS, HEADACHE, DEPRESSION, AND TROUBLE SLEEPING. ON (B)(6) 2012 THE PATIENT PRESENTED WITH LUMBAR POST-LAMINECTOMY SYNDROME. THE PATIENT UNDERWENT HARDWARE REMOVAL L3-S1 AND EXPLORATION OF LUMBAR FUSION. THERE WERE NO NOTED COMPLICATIONS. ON (B)(6) 2012 THE PATIENT PRESENTED FOR EVALUATION OF THE INCISION. PATIENT HAD COMPLAINTS OF NECK PAIN AND SORENESS IN HER BACK. PER THE PHYSICIAN¿S NOTES, ¿THERE WAS NO EVIDENCE OF INFECTION OR SWELLING.¿ ON (B)(6) 2013 THE PATIENT PRESENTED WITH COMPLAINTS OF RIGHT-SIDED LOW BACK PAIN AND RIGHT ANTERIOR THIGH PAIN. THE PATIENT ALSO COMPLAINED OF HER BODY TILTING TO THE LEFT CAUSING DIFFICULTY STANDING STRAIGHT. THE PATIENT¿S GAIT WAS ANTALGIC, AND THE PATIENT USED A CANE TO AMBULATE. X-RAYS INDICATED ¿DEGENERATIVE SCOLIOSIS. THERE WAS EVIDENCE OF A PREVIOUS FUSION FROM L3-S1.¿ ON (B)(6) 2013 THE PATIENT PRESENTED WITH BACK PAIN WITH WEAKNESS AND NUMBNESS IN BOTH LEGS. MRI OF THE LUMBAR SPINE INDICATED ¿POSTOPERATIVE CHANGES FROM POSTERIOR DECOMPRESSION AND SPINAL FUSION AT L4-L5 AND L5-S1. THERE IS NO RESIDUAL DISC DISEASE, SPINAL STENOSIS OR NEURAL FORAMINAL ENCROACHMENT. RIGHT PARACENTRAL DISC PROTRUSION AT L2-L3. DISC BULGES AT T12-L1, L1-L2, AND L3-L4.¿
IT WAS REPORTED THAT ON (B)(6) 2008 THE PATIENT'S MRI OF THE LUMBAR SPINE WAS REVIEWED. IT DEMONSTRATED A SPONDYLOLISTHESIS AT L5-S1. THERE WAS SEVERE DEGENERATIVE DISC DISEASE AT L5-S1 WITH MODIC ENDPLATE CHANGES. THE PATIENT ALSO UNDERWENT MRI OF THE KNEE. IMPRESSION: SEVERE TRICOMPARTMENTAL DEGENERATIVE CHANGES, AS DESCRIBED WITH MODERATE BONE MARROW EDEMA. MICROFRACTURES ARE NOT EXCLUDED; COMPLETE TEAR OF THE LATERAL MENISCUS; SPRAIN OR PARTIAL TEAR OF THE ANTERIOR ERUCTATE LIGAMENT. FULL THICKNESS TEAR IS NOT EXCLUDED; QUESTION SMALL DEGENERATIVE TEAR OF THE POSTERIOR HORN OF THE MEDIAL MENISCUS. ON (B)(6) 2008 THE PATIENT UNDERWENT A CLINICAL TEST OF THE CHEST. IMPRESSION: SLIGHT CARDIOMEGALY; NO RADIOGRAPHIC ABNORMALITY OF ANY ACUTE PROCESS; THERE IS NO SIGNIFICANT CHANGE WHEN COMPARED WITH THE PREVIOUS CHEST FILM, EXCEPT FOR SLIGHT DIFFERENCE IN TECHNIQUE (B)(6) 2008 THE PATIENT WAS DIAGNOSED WITH: DEGENERATIVE DISC DISEASE AT L5-S 1; SPONDYLOLISTHESIS AT L4-L5 AND L5-S1. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: DECOMPRESSIVE LAMINECTOMY L4-S1; POSTEROLATERAL FUSION FROM L3 TO S 1; POSTERIOR INTERBODY FUSION. L4-L5 AND L5-S1; USE OF ANTERIOR BIOMECHANICAL DEVICE X2 WITH USE OF A K2M PEEK ANTERIOR BIOMECHANICAL CAGE. ONE CAGE WAS PLACED AT L4-L5 AND ANOTHER CAGE WAS PLACED AT L5-S1; PEDICLE SCREW INSTRUMENTATION SYSTEM FROM L3-S1 WITH USE A BIOMET PEDICLE SCREW INSTRUMENTATION SYSTEM; USE OF LOCAL AUTOGRAFT; USE OF ALLOGRAFT; USE OF BONE MORPHOGENIC PROTEIN; USE OF MICROSCOPE; SSEP AND EMG MONITORING. PER OP NOTES: INCISION WAS PROXIMALLY EXTENDED UP TO THE L3 REGION, THEN USING ANATOMIC LANDMARKS, PEDICLE SCREWS WERE PLACED BILATERALLY AT L3. THEN LASKELL RONGEUR WAS USED TO REMOVE SUPRASPINOUS LIGAMENT AND INTERSPINOUS LIGAMENT FROM L3-S1. THE SPINOUS PROCESSES WERE HARVESTED. WE CLEANED THAT BONE FOR INTERBODY AND POSTEROLATERAL FUSION. THEN A HIGH SPEED DRILL WAS USED TO PERFORM A DECOMPRESSIVE LAMINECTOMY FROM L4-S1. ATTENTION WAS THEN PAID TO THE L5-S1 SEGMENT AND THE THECAL SAC WAS RETRACTED TO THE MIDLINE, PERFORMED A BOX ANNULOTOMY AT L5-S1 FOLLOWED BY A COMPLETE DISKECTOMY USING MULTIPLE SIZE PITUITARY RONGEURS, ENDPLATES SHAVERS AND CURETTES. ONCE THE END PLATES WERE PREPARED DOWN TO BLEEDING BONE, PACKED LOCAL BONE GRAFT ALONG WITH LOCAL BONE MORPHOGENIC PROTEIN IN ADDITION TO A K2M PEEK ANTERIOR BIOMECHANICAL CAGE INTO THE DISC SPACE AT L5-S1. THE THECAL SAC WAS ALLOWED TO RETRACT TO THE MIDLINE. ON (B)(6) 2010 THE PATIENT'S EMG REPORTS WERE REVIEWED. DIAGNOSIS: STATUS POST LUMBAR LAMINECTOMY AND FUSION FROM L3 TO S1. LEFT C6 AND C7 RADICULOPATHY. ON (B)(6) 2010 THE PATIENT PRESENTED FOR PHYSICAL THERAPY OF CERVICAL AND LUMBAR SPINE. DIAGNOSIS:DDD. ON (B)(6) 2010 THE PATIENT PRESENTED FOR A RECHECK OF RIGHT TKA (B)(6) 2011 THE PATIENT PRESENTED WITH A CHIEF COMPLAINT OF ABDOMINAL PAIN, NAUSEA AND VOMITING AND PROBABLY NARCOTIC WITHDRAWAL. ON (B)(6) 2012 THE PATIENT UNDERWENT CT OF THE LUMBAR SPINE WITHOUT CONTRAST. DIAGNOSIS: DEGENERATION LUMBAR DISC. ON (B)(6) 2012 THE PATIENT PRESENTED WITH PAIN. THE PATIENT UNDERWENT CT OF THE LUMBAR SPINE W/O CONTRAST. IMPRESSION: POSTOPERATIVE AND DEGENERATIVE CHANGES WITHOUT EVIDENCE OF FOCAL DISK HERNIATION OR SPINAL STENOSIS. ON (B)(6) 2012 THE PATIENT PRESENTED FOR EVALUATION OF INCISION. HISTORY OF PRESENT ILLNESS: THE PATIENT UNDERWENT REMOVAL OF HARDWARE FROM L3 TO S1 ON (B)(6) 2012 AND WAS DOING WELL AFTER SURGERY. THE PATIENT ALSO PREVIOUSLY UNDERWENT A LUMBAR LAMINECTOMY AND FUSION FROM L3 TO S1 ON (B)(6) 2008. THE PATIENT RETURNED TODAY COMPLAINING OF NECK PAIN AND SORENESS IN HER BACK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 393629 | INFUSE BONE GRAFT | FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET | NEK | MEDTRONIC SOFAMOR DANEK USA, INC | NA | M110703AAD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |