INFUSE BONE GRAFT
Report
- Report Number
- 1030489-2014-02981
- Event Type
- Injury
- Date Received
- June 30, 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). 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.
(B)(4).
IT WAS REPORTED THAT ON: (B)(6) 2009: THE PATIENT UNDERWENT MRI OF LUMBAR SPINE. IMPRESSION: L4 AND L5 POSTERIOR SPINAL FUSION; 1 CM HYPOINTENSE T1 FOCUS IN THE RIGHT NEURAL FORAMEN, CAUSING MODERATE RIGHT NEURAL FORAMINAL NARROWING. ON (B)(6) 2009: THE PATIENT WAS ADMITTED WITH THE FOLLOWING DIAGNOSIS: LUMBOSACRAL DISC DEGENERATION. HE UNDERWENT THE FOLLOWING PROCEDURES: DISCOGRAPHY INJECTION, LUMBAR, EACH LEVEL. FUNCTIONAL ANESTHETIC DISCOGRAM, LUMBAR. FLUORO GUIDANCE AND LOCALIZED NEEDLE/CATHETER SPINE INJECTION. SEDATION WITH ¿ANALOG¿; INTRAVENOUS IM/INHALATION. HE WAS DISCHARGED THE SAME DAY. ON (B)(6) 2010: THE PATIENT PRESENTED FOR FOLLOW-UP WITH LOW BACK PAIN GOING TO MID LUMBAR ON THE RIGHT. HE ALSO HAD ISOLATED ANKLE/LATERAL FOOT PAIN. PATIENT LEG SYMPTOMS WERE WORSE WITH WALKING, STANDING AND SITTING. MRI OF THE LUMBAR SPINE REVEALED MODERATE DEGENERATIVE DISK DISEASE AT L4-5, DISC BULGE, MILD BILATERAL FORAMINAL STENOSIS, LEFT GREATER THAN RIGHT. ON (B)(6) 2010: THE PATIENT PRESENTED FOR PRE-OPERATIVE EXAMINATION WITH LOW BACK PAIN GOING TO MID LUMBAR ON THE RIGHT; ISOLATED RIGHT ANKLE/LATERAL FOOT PAIN. IMPRESSION: L4-5 MODERATE DEGENERATIVE DISC DISEASE, DISC BULGE, MILD BILATERAL FORAMINAL STENOSIS, LEFT GREATER THAN RIGHT. ON (B)(6) 2010: THE PATIENT PRESENTED FOR PRE-OPERATIVE EXAMINATION WITH LOW BACK PAIN GOING TO MID LUMBAR ON THE RIGHT; ISOLATED RIGHT ANKLE/LATERAL FOOT PAIN. IMPRESSION: L4-5 MODERATE DEGENERATIVE DISC DISEASE, DISC BULGE, MILD BILATERAL FORAMINAL STENOSIS, LEFT GREATER THAN RIGHT. ON (B)(6) 2010: THE PATIENT WAS ADMITTED WITH THE FOLLOWING DIAGNOSIS: SPINAL SPONDYLOSIS L4-5 AND MILD BILATERAL FORAMINAL STENOSIS. HE UNDERWENT THE FOLLOWING PROCEDURES: POSTERIOR FUSION, INSTRUMENTATION, RIGHT HEMILAMINECTOMY L4-5; TLIF AT L4-5. THE FOLLOWING IMPLANTS WERE ALSO USED IN THE SURGERY: INSTRUMENTATION; CAGE TLIF ALLOGRAFT. PER OP NOTES, L4-5 LEVEL DISC WAS IDENTIFIED. DISC MATERIAL WAS REMOVED. THEN APPROPRIATE SIZE TRIAL WAS INTRODUCED IN THE DISC SPACE THROUGH ANATOMY WITH GOOD FIT. THE CENTRAL ASPECT OF THE DISC SPACE WAS THEN PACKED WITH RH-BMP2/ACS, LOCAL BONE AUTOGRAFT AND BONE EXTENDERS. THE APPROPRIATE SIZED TLIF WAS THEN INSERTED INTO THE DISC SPACE. THE ADEQUATE POSITION OF THE TLIF CAGE WAS VERIFIED WITH X-RAY IMAGING. THEN, DECORTICATION WAS PERFORMED FROM L4 TO L5. RH-BMP2/ACS WAS THEN ROLLED UP AND POSITIONED OVER THE POSTERIOR LATERAL GUTTER SPANNING FROM L4 TO L5. NO COMPLICATIONS WERE REPORTED. 02 APR 2010: THE PATIENT UNDERWENT X-RAY OF LUMBOSACRAL SPINE, INTRA-OP. FINDINGS: TWO INTRAOPERATIVE IMAGES REVEALS POSTERIOR FIXATION OF L4-L5 WITH TRANSPEDICULAR SCREWS AND POSTERIOR RODS; ALIGNMENT IS SATISFACTORY; L4-5 INTRAVERTEBRAL DISK BONE SPACERS NOTED; NO ACUTE FRACTURES. ON (B)(6) 2010: THE PATIENT WAS DISCHARGED WITH THE FOLLOWING DIAGNOSIS: DEGENERATION OF LUMBOSACRAL INTERVERTEBRAL DISC. ON (B)(6) 2010: THE PATIENT PRESENTED FOR POSTOPERATIVE EXAMINATION. HE COMPLAINED OF INCISIONAL PAIN AND NIGHT DISTURBANCES. THE PAIN WAS CONSISTENT WITH MUSCULAR ACHE/SORENESS. ON (B)(6) 2010: THE PATIENT PRESENTED FOR AN OFFICE VISIT WITH BACK PAIN. HE ALSO COMPLAINED OF RIGHT LEG PAIN (BUTTOCKS, ANTERIOR THIGH INTO THE RIGHT TESTICLE, ANTERIOR SHIN AND TOP OF FOOT). THE PAIN WAS DESCRIBED AS SHOOTING, BRIEF AND INTERMITTENT. ON (B)(6) 2010: THE PATIENT UNDERWENT CT OF LUMBAR SPINE. IMPRESSION: SATISFACTORY LOWER LUMBAR FUSION WITH LUMBAR LAMINECTOMIES AT L4-5 WITH PLACEMENT AND TRANSFIXING PEDICULATE SCREWS AT THESE LEVELS. ON (B)(6) 2011: THE PATIENT PRESENTED WITH LOW BACK PAIN. THE PATIENT ALSO COMPLAINED OF LEFT SHOULDER PAIN SINCE THE FALL, ONE MONTH AGO, WITH DECREASED RANGE OF MOTION AND PAIN. HE ALSO NOTED PERSISTENT RIGHT LEG PAIN MORE IN THE ANTERIOR PART OF THE LEG. THE FOLLOWING DIAGNOSTIC EXAMINATIONS WERE PERFORMED: X-RAY OF THE LUMBOSACRAL SPINE REVEALED HARDWARE STABLE AND FUSED. MRI OF LUMBAR SPINE REVEALED L4-5 RIGHT HEMILAMINECTOMY, TLIF, NO SIGNIFICANT STENOSIS AND HARDWARE INTACT. CT REVEALED L4-5 TLIF AND POSTERIOR FUSION, ALL FUSED, HARDWARE INTACT. X-RAY OF CERVICAL SPINE WAS DONE DUE TO NECK PAIN, WHICH REVEALED NORMAL CERVICAL SPINE. MRI OF THE CERVICAL SPINE REVEALED DEGENERATIVE CHANGES WITH NEURAL FORAMINAL STENOSIS AT C4-5, C5-6, AND C6-7. ON (B)(6) 2011: THE PATIENT UNDERWENT MRI OF CERVICAL SPINE. ON (B)(6) 2011: THE PATIENT CALLED AND COMPLAINED OF BILATERAL ARM PAIN WITH NUMBNESS IN LEFT HAND GOING TO HIS FINGERS. HE ALSO NOTED PAIN WHILE WALKING ON THE BACK OF HIS RIGHT SIDE PELVIC, WHICH ON TOUCH RADIATED TO HIS KNEE/SHIN/FEET.
IT WAS REPORTED THAT ON (B)(6) 2009 THE PATIENT PRESENTED WITH LUMBOSACRAL DISC DEGENERATION. PATIENT UNDERWENT LUMBAR PROVOCATIVE DISCOGRAM L3-4-5 AND FUNCTIONAL ANESTHETIC DISCOGRAM L4-5. CONCLUSION: ¿PROVOCATIVE DISCOGRAM @ L4/5 DISC WITH CONCORDANT PAIN BUT NO FAD IMPROVEMENT IN ACTIVITIES POST INJECTION¿¿ ON (B)(6) 2010 PATIENT PRESENTED FOR AN OFFICE VISIT WITH COMPLAINTS OF LOW BACK PAIN GOING TO MID LUMBAR ON THE RIGHT, NO RADIATING LEG PAIN, ISOLATED RIGHT ANKLE/LATERAL FOOT PAIN, WHICH DOES NOT RADIATE. NEW LEFT BACK PAIN DESCRIBED AS SHOOTING. SURGERY WAS DISCUSSED. ON (B)(6) 2010 PATIENT PRESENTED FOR SURGERY. SURGERY WAS CANCELLED DUE TO HISTORY OF EXERTIONAL CHEST PAIN FOUND PRE-OP BY ANESTHESIA. PATIENT WAS DISCHARGED. ON (B)(6) 2010 THE PATIENT PRESENTED FOR PRE-OP EXAMINATION. ON (B)(6) 2010 THE PATIENT PRESENTED FOR SURGERY. PATIENT UNDERWENT PSF, LAMINECTOMY, AND TLIF L4-5 USING RHBMP-2/ACS, LOCAL AUTOGRAFT, ALLOGRAFT SPACER, MASTERGRAFT, AND SYNTHES POSTERIOR INSTRUMENTATION. INTRAOPERATIVE X-RAYS INDICATED ¿POSTERIOR FIXATION OF L4-L5 WITH TRANSPEDICULAR SCREWS AND POSTERIOR RODS. ALIGNMENT IS SATISFACTORY. L4-5 INTRAVERTEBRAL DISC BONE SPACERS NOTED. NO ACUTE FRACTURES.¿ THERE WERE NO NOTED COMPLICATIONS. ON PATIENT WAS DISCHARGED ON (B)(6) 2010. ON (B)(6) 2010 PATIENT PRESENTED FOR POST-OP FOLLOW UP. PATIENT REPORTED AVERAGE PAIN W/O PAIN MEDS, PAIN 6/10. PREOP SYMPTOMS OF MID LUMBAR PAIN WITH ISOLATED RIGHT ANKLE/FOOT PAIN IS IMPROVED. NO EVIDENCE OF INFECTION. X-RAYS INDICATED ¿ACCEPTABLE ALIGNMENT, HARDWARE IN PLACE, NO SIGNS OF LOOSENING.¿ ON (B)(6) 2010 PATIENT PRESENTED FOR POST-OP FOLLOW UP WITH COMPLAINTS OF INCISIONAL PAIN WITHOUT RADICULAR SPREAD OR EXTREMITY WEAKNESS. ON (B)(6) 2010 PATIENT PRESENTED FOR POST-OP FOLLOW UP WITH COMPLAINTS OF INCISIONAL PAIN WITHOUT RADICULAR SPREAD OR EXTREMITY WEAKNESS. X-RAYS INDICATED ¿ACCEPTABLE ALIGNMENT, HARDWARE IN PLACE, NO SIGNS OF LOOSENING WITH GOOD PROGRESSION OF FUSION AT ALLOGRAFT AND POSTERIOR LATERAL ZONES.¿ ON (B)(6) 2010 THE PATIENT PRESENTED WITH COMPLAINTS OF ¿NEW ONSET OF RIGHT LEG PAIN (BUTTOCKS, ANTERIOR THIGH INTO THE RIGHT TESTICLE, ANTERIOR SHIN AND TOP OF FOOT) DESCRIBED AS SHOOTING, BRIEF AND INTERMITTENT. WORSE WITH PROLONGED ACTIVITY.¿ X-RAYS INDICATED ¿A CCEPTABLE ALIGNMENT, HARDWARE IN PLACE, BILATERAL L5 SCREW SIGNS OF LOOSENING (RIGHT GREATER THAN LEFT)? GOOD PROGRESSION OF FUSION AT ALLOGRAFT AND POSTERIOR LATERAL ZONES.¿ ON (B)(6) 2010 MRI OF THE LUMBAR SPINE INDICATED ¿L4 AND L5 POSTERIOR SPINAL FUSION. 1CM HYPOINTENSE T1 FOCUS IN THE RIGHT NEURAL FORAMEN, MAY REPRESENT A BONE GRAFT, CAUSING MODERATE RIGHT NEURAL FORAMINAL NARROWING.¿ CT OF THE LUMBAR SPINE INDICATED ¿THE PATIENT IS STATUS POST SATISFACTORY LOWER LUMBAR FUSION WITH LUMBAR LAMINECTOMIES AT L4-5 WITH PLACEMENT AND TRANSFIXING PEDICULATE SCREWS AT THESE LEVELS.¿ ON (B)(6) 2011 THE PATIENT PRESENTED WITH LOW BACK PAIN. PATIENT REPORTED FALL APPROXIMATELY 1 MONTH AGO WITH LEFT SHOULDER/ARM PAIN SINCE AND DECREASED RANGE OF MOTION AND PAIN. PERSISTENT RIGHT LEG PAIN MORE IN THE ANTERIOR PART OF THE LEG. RECENT INCREASE IN PAIN MEDICATION USE. PHYSICIAN¿S ASSESSMENT: ¿STATUS POST L4/5 HEMILAMI, POSTERIOR FUSION, TLIF ¿ FUSED, NO SIGNIFICANT STENOSIS, STABLE. RIGHT LEG PAIN¿ LIKELY NOT RELATED TO SPINE. LEFT SHOULDER/ARM PAIN AND FROZEN SHOULDER. PAIN SYNDROME AND NARCOTIC USE. STABLE POSTOP FROM SPINE PERSPECTIVE. PERSISTENT BACK PAIN AND RIGHT LEG PAIN WITHOUT EVIDENCE OF RADICULOPATHY. NEW LEFT SHOULDER/ARM PAIN SINCE THE FALL. PLAN: CONTINUE WITH CURRENT PSYCH TREATMENT AND PAIN SYNDROME.¿
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 379220 | INFUSE BONE GRAFT | FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET | NEK | MEDTRONIC SOFAMOR DANEK USA, INC | NA | M110811AAG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |