INFUSE BONE GRAFT
Report
- Report Number
- 1030489-2013-00395
- Event Type
- Injury
- Date Received
- February 6, 2013
- Report Date
- January 9, 2017
- 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
(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.
(B)(4).
(B)(4).
IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY FOR TREATMENT OF DEGENERATIVE DISC DISEASE AND HERNIATED DISC L4-L5 AND L5-S1. PROCEDURE WAS FOR RIGHT SIDED TLIF AT L4-L5 AND L5-S1 WITH INTERBODYAGES, RHBMP-2/ACS, AND RESORBABLE CERAMIC GRANULES AND POSTEROLATERAL FUSION L4, L5, AND S1 BILATERALLY WITH RHBMP-2/ACS AND LOCAL BONE AND BILATERAL PEDICLE SCREW INSTRUMENTATION. AT EACH LEVEL, RHBMP-2 SPONGES WERE PADDED INTO THE DISC SPACE AND CORTICAL CANCELLOUS BONE WAS PLACED IN THE CAGE. FOR POSTERIOR FUSION, ON THE RIGHT SIDE A LARGE RHBMP-2/ACS SPONGE WITH RESORBABLE CERAMIC GRANULES WAS PLACED IN THE LATERAL GUTTER FROM TRANSVERSE PROCESS OF L3 TO THE SACRAL; CORTICAL CANCELLOUS BONE WAS PLACED ON THE LEFT SIDE. FIFTEEN DAYS POST-OP, THE PATIENT PRESENTED FOR FOLLOW-UP. PER THE PHYSICIAN'S NOTES, "THE PATIENT REPORTS THAT HE HAS BEEN DOING MUCH BETTER AS FAR AS HIS PAIN CONTROL IS CONCERNED. HE CONTINUES TO HAVE MODERATE AND AT TIMES SEVERE PAIN ACROSS HIS LOW BACK WITH OCCASIONAL RADIATION TO HIS RIGHT GREATER THAN LEFT POSTERIOR THIGHS." "HE ALSO NOTED IMMEDIATELY FOLLOWING SURGERY THAT HIS RIGHT MEDIAL CALF WAS NUMB AND THAT HE WAS HAVING INCREASED SPASMS IN HIS RIGHT LEG, ALTHOUGH HE NOTES THAT THESE HAVE BOTH IMPROVED SOMEWHAT." "THE PATIENT IS USING A BONE STIMULATOR FOR 30 MINUTES A DAY." FORTY-THREE DAYS POST-OP, THE PATIENT PRESENTED FOR FOLLOW-UP. PER THE PHYSICIAN'S NOTES, "THE PATIENT REPORTS THAT HE CONTINUES TO HAVE PERSISTENT PAIN ACROSS HIS LOW BACK WITH RADIATION DOWN BOTH OF HIS THIGHS." EIGHTY-FIVE DAYS POST-OP, THE PATIENT PRESENTED FOR FOLLOW-UP. PER THE PHYSICIAN'S NOTES, THE PATIENT "CONTINUES TO SUFFER WITH PERSISTENT PAIN IN HIS RIGHT GREATER THAN LEFT LOW BACK AND PROXIMAL RIGHT LOWER EXTREMITY AS DETAILED ABOVE. WHILE HE HAS BEEN ASSURED BY DR. (B)(6) THAT HIS SURGICAL HARDWARE IS IN PLACE AND THAT HE IS HEALING AS EXPECTED, I INFORMED THE PATIENT THAT I AM CONCERNED BY THE PERSISTENCE OF HIS RIGHT LOW BACK, ESPECIALLY AS THESE HAVE BEEN PRESENT PREDOMINATELY SINCE HIS SURGERY." AT 176 DAYS POST-OP, THE PATIENT PRESENTED FOR FOLLOW-UP. PER THE PHYSICIAN'S NOTES, "HE NOTES THAT HIS RIGHT LOWER EXTREMITY PAIN HAS DEFINITELY IMPROVED. HE NO LONGER HAS ANY PAIN IN HIS DISTAL RIGHT LOWER EXTREMITY HOWEVER HE DOES CONTINUE TO HAVE PAIN, WHICH RADIATES FROM HIS RIGHT BUTTOCK TO HIS RIGHT THIGH AND KNEE. HE NOTES THAT HIS PROXIMAL RIGHT LOWER EXTREMITY ALSO FREQUENTLY "FEELS FATIGUED." HE CONTINUES TO HAVE LOW BACK PAIN, WHICH HAS NOT IMPROVED SINCE HIS SURGERY AND WHICH HE SAYS IS MOST TIME WORSE THAN BEFORE HIS LUMBAR SPINE SURGERY EARLIER THIS YEAR." AT 326 DAYS POST-OP, A LUMBAR MRI WAS PERFORMED AND INTERPRETED TO INDICATE "STATUS POST FUSION OF L4-5 AT L5-S1, WITH OSTEOPHYTES NOTED AT L4-5 MORE PROMINENT ON THE RIGHT POSSIBLY IMPINGING THE EXITING NERVE ROOTS. BROAD BASED DISK BULGE AT TO L2-3 WITH MODERATE CANAL STENOSIS. BROAD BASED DISK BULGE AT L3-4 WITH MILD CANAL STENOSIS." "ANTERIOR AND POSTERIOR FUSION IS NOTED WITH LAMINECTOMY AT L4-L5 AND L5-S1. BONY UNION IS NOTED ANTERIORLY. BONE PLUGS HAVE BEEN INSERTED VIA A RIGHT-SIDED APPROACH. POSTERIOR TO THE BONE PLUGS AT THE ABOVE LEVELS, BONY OSTEOPHYTIC RIDGING IS IDENTIFIED WHICH NARROWS THE RIGHT LATERAL EPIDURAL RECESSES AND NEURAL CANALS OF L4 AND L5." AT 361 DAYS POST-OP, A MRI WAS INTERPRETED TO INDICATE "L5-S1 SUSPECTED RECURRENT/RESIDUAL DISC PROTRUSION WHICH INVAGINATES THE ANTERIOR DURAL TUBE, HOWEVER, DOES NOT APPEAR TO CAUSE SIGNIFICANT CENTRAL CANAL STENOSIS. L2-L3 AND L3-L4 MILD CENTRAL AND BILATERAL NEURAL CANAL STENOSIS SECONDARY TO BROAD-BASED POSTERIOR DISC BULGES, LIGAMENTUM FLAVUM THICKENING AND FACET ARTHROPATHY." AT 365 DAYS POST-OP, AN MRI WAS INTERPRETED TO INDICATE "RECURRENT DISK PROTRUSION L5-S1 WITHOUT SIGNIFICANT CENTRAL CANAL STENOSIS." AT 860 DAYS POST-OP, AN MRI WAS INTERPRETED TO INDICATE "AT L2-L3, THERE IS BULGING INTERVERTEBRAL DISK INDENTING THE VENTRAL THECAL SAC. THERE IS FACET JOINT SCLEROSIS. THERE IS MODERATE CENTRAL CANAL STENOSIS. THERE IS MILD BILATERAL NEURAL FORAMINAL STENOSIS. THERE ARE ANTERIOR OSTEOPHYTES. AT L3-L4, THERE IS MILD BULGING INTERVERTEBRAL DISK. THERE IS FACET JOINT ARTHROPATHY. THERE IS MODERATE CENTRAL CANAL STENOSIS. THERE IS MILD RIGHT NEURAL FORAMINAL STENOSIS. THERE IS MILD TO MODERATE LEFT NEURAL FORAMINAL STENOSIS. AT 1035 DAYS POST-OP, THE PATIENT PRESENTED FOR FOLLOW-UP. PER THE PHYSICIAN'S NOTES, "HE REPORTS NECK, SHOULDER, BACK, HIP, AND LEG PAIN. HE STATES THIS BEGAN IN 2006 AFTER AN AUTO ACCIDENT."
ON (B)(6) 2008 ¿ PT. UNDERWENT SURGERY FOR TREATMENT OF DEGENERATIVE DISC DISEASE AND HERNIATED DISC L4-L5 AND L5-S1. PROCEDURE WAS FOR RIGHT SIDED TLIF AT L4-L5 AND L5-S1 WITH CAPSTONE CAGES, INFUSE, AND MASTERGRAFT AND POSTEROLATERAL FUSION L4, L5, AND S1 BILATERALLY WITH INFUSE AND LOCAL BONE AND BILATERAL PEDICLE SCREW INSTRUMENTATION. AT EACH LEVEL, INFUSE SPONGES WERE PADDED INTO THE DISC SPACE AND CORTICAL CANCELLOUS BONE WAS PLACED IN THE CAPSTONE CAGE. FOR POSTERIOR FUSION, ON THE RIGHT SIDE A LARGE INFUSE SPONGE WITH MASTERGRAFT WAS PLACED IN THE LATERAL GUTTER FROM TRANSVERSE PROCESS OF L3 TO THE SACRAL; CORTICAL CANCELLOUS BONE WAS PLACED ONTHE LEFT SIDE. ON (B)(6) 2008 ¿ PT PRESENTS FOR FOLLOW-UP. ¿THE PATIENT REPORTS THAT HE HAS BEEN DOING MUCH BETTER AS FAR AS HIS PAIN CONTROL IS CONCERNED. HE CONTINUES TO HAVE MODERATE AND AT TIMES SEVERE PAIN ACROSS HIS LOW BACK WITH OCCASIONAL RADIATION TO HIS RIGHT GREATER THAN LEFT POSTERIOR THIGHS." ¿HE ALSO NOTED IMMEDIATELY FOLLOWING SURGERY THAT HIS RIGHT MEDIAL CALF WAS NUMB AND THAT HE WAS HAVING INCREASED SPASMS IN HIS RIGHT LEG, ALTHOUGH HE NOTES THAT THESE HAVE BOTH IMPROVED SOMEWHAT.¿ ¿THE PATIENT IS USING A BONE STIMULATOR FOR 30 MINUTES A DAY.¿ ON (B)(6) 2008 ¿ PT. PRESENTS FOR FOLLOW-UP. ¿THE PATIENT REPORTS THAT HE CONTINUES TO HAVE PERSISTENT PAIN ACROSS HIS LOW BACK WITH RADIATION DOWN BOTH OF HIS THIGHS.¿ ON (B)(6) 2008 ¿ PT PRESENTS FOR FOLLOW-UP. PATIENT ¿CONTINUES TO SUFFER WITH PERSISTENT PAIN IN HIS RIGHT GREATER THAN LEFT LOW BACK AND PROXIMAL RIGHT LOWER EXTREMITY AS DETAILED ABOVE. WHILE HE HAS BEEN ASSURED BY DR (B)(6) THAT HIS SURGICAL HARDWARE IS IN PLACE AND THAT HE IS HEALING AS EXPECTED, I INFORMED THE PATIENT THAT I AM CONCERNED BY THE PERSISTENCE OF HIS RIGHT LOW BACK, ESPECIALLY AS THESE HAVE BEEN PRESENT PREDOMINATELY SINCE HIS SURGERY.¿ ON (B)(6) 2008 ¿ PT PRESENTS FOR FOLLOW-UP. ¿HE NOTES THAT HIS RIGHT LOWER EXTREMITY PAIN HAS DEFINITELY IMPROVED. HE NO LONGER HAS ANY PAIN IN HIS DISTAL RIGHT LOWER EXTREMITY HOWEVER HE DOES CONTINUE TO HAVE PAIN, WHICH RADIATES FROM HIS RIGHT BUTTOCK TO HIS RIGHT THIGH AND KNEE. HE NOTES THAT HIS PROXIMAL RIGHT LOWER EXTREMITY ALSO FREQUENTLY "FEELS FATIGUED¿. HE CONTINUES TO HAVE LOW BACK PAIN, WHICH HAS NOT IMPROVED SINCE HIS SURGERY AND WHICH HE SAYS IS MOST TIME WORSE THAN BEFORE HIS LUMBAR SPINE SURGERY EARLIER THIS YEAR.¿ ON (B)(6) 2008 ¿ LUMBAR MRI. ¿STATUS POST FUSION OF L4-5 AT L5-S1, WITH OSTEOPHYTES NOTED AT L4-5 MORE PROMINENT ON THE RIGHT POSSIBLY IMPINGING THE EXITING NERVE ROOTS. BROAD BASED DISK BULGE AT TO L2-3 WITH MODERATE CANAL STENOSIS. BROAD BASED DISK BULGE AT L3-4 WITH MILD CANAL STENOSIS.¿ ¿ANTERIOR AND POSTERIOR FUSION IS NOTED WITH LAMINECTOMY AT L4-L5 AND L5-S1. BONY UNION IS NOTED ANTERIORLY. BONE PLUGS HAVE BEEN INSERTED VIA A RIGHT-SIDED APPROACH. POSTERIOR TO THE BONE PLUGS AT THE ABOVE LEVELS, BONY OSTEOPHYTIC RIDGING IS IDENTIFIED WHICH NARROWS THE RIGHT LATERAL EPIDURAL RECESSES AND NEURAL CANALS OF L4 AND L5.¿ ON (B)(6) 2009 ¿ MRI SHOWS¿L5-S1 SUSPECTED RECURRENT/RESIDUAL DISC PROTRUSION WHICH INVAGINATES THE ANTERIOR DURAL TUBE, HOWEVER, DOES NOT APPEAR TO CAUSE SIGNIFICANT CENTRAL CANAL STENOSIS. L2-L3 AND L3-L4 MILD CENTRAL AND BILATERAL NEURAL CANAL STENOSIS SECONDARY TO BROAD-BASED POSTERIOR DISC BULGES, LIGAMENTUM FLAVUM THICKENING AND FACET ARTHROPATHY.¿ ON (B)(6) 2009 ¿ MRI SHOWS ¿RECURRENT DISK PROTRUSION L5-S1 WITHOUT SIGNIFICANT CENTRAL CANAL STENOSIS.¿ ON (B)(6) 2010 ¿ MRI SHOWS ¿AT L2-L3, THERE IS BULGING INTERVERTEBRAL DISK INDENTING THE VENTRAL THECAL SAC. THERE IS FACET JOINT SCLEROSIS. THERE IS MODERATE CENTRAL CANAL STENOSIS. THERE IS MILD BILATERAL NEURAL FORAMINAL STENOSIS. THERE ARE ANTERIOR OSTEOPHYTES. AT L3-L4, THERE IS MILD BULGING INTERVERTEBRAL DISK. THERE IS FACET JOINT ARTHROPATHY. THERE IS MODERATE CENTRAL CANAL STENOSIS. THERE IS MILD RIGHT NEURAL FORAMINAL STENOSIS. THERE IS MILD TO MODERATE LEFT NEURAL FORAMINAL STENOSIS. ON (B)(6) 2010 ¿ PT. PRESENTS TO NEW YORK SPINE AND REHABILITATION. ¿HE REPORTS NECK, SHOULDER, BACK, HIP, AND LEG PAIN. HE STATES THIS BEGAN IN 2006 AFTER AN AUTO ACCIDENT.¿
IT WAS REPORTED THAT ON: (B)(6) 2008: THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH DEGENERATIVE DISC DISEASE WITH HERNIATED DISC, L4-L5 AND L5-S1 AND UNDERWENT THE FOLLOWING PROCEDURES: POSTERIOR LUMBAR INTERBODY FUSION, L4-L5 WITH POSTERIOR INTERBODY FUSION L5-S1 USING INTERBODY CAGE DEVICE AT BOTH LEVELS WITH RHBMP-2 PRODUCT WITH BONE GRAFT AND POSTEROLATERAL FUSION L4-L5-S1 BILATERALLY WITH BMP AND LOCAL AUTOGENOUS BONE GRAFT AND BILATERALLY PEDICLE SCREW INSTRUMENTATION. UNDER FLUOROSCOPIC GUIDANCE WITH INTRAOPERATIVE RUNNING EMG AND EVOKED EMG MONITORING. AS PER OP-NOTES, "THE END PLATES OF L5 AND S1 WERE SCRAPED DOWN TO BLEEDING BONE. THERE WAS AN ABUNDANT QUANTITY OF HIGH QUALITY CORTICAL CANCELLOUS BONE OBTAINED FROM THE LAMINECTOMY PROCEDURE. THIS BONE WAS UTILIZED FOR FUSION. RHBMP-2 WAS ALSO USED. THE RHBMP-2 SPONGES WERE PACKED INTO THE DISC SPACE AT L5-S1 FORMING A CONFLUENCE OF PRODUCT BETWEEN DECORTICATED END PLATES FOR THE INTERBODY FUSION TO OCCUR. THE SAME TECHNIQUE WAS DONE AT THE LEVEL L4-L5 FOR A TOTAL OF TWO CAGES IMPLANTED. THE PATIENT UNDERWENT X-RAY OF SPINE. IMPRESSION: STATUS POST SPINAL FUSION OF L4, L5, S1 VERTEBRAE. ON (B)(6) 2008: THE PATIENT UNDERWENT CT OF LUMBAR SPINE DUE TO LOW BACK PAIN, HISTORY OF MVA AND PRIOR SPINAL FUSION. IMPRESSION: STATUS POST FUSION OF L4-L5 AT L5-S1, WITH OSTEOPHYTES NOTED AT L4-L5 MORE PROMINENT ON THE RIGHT POSSIBLY IMPINGING THE EXITING NERVE ROOTS. BROAD BASED DISC BULGE AT L2-L3 WITH MODERATE CANAL STENOSIS. BROAD BASED DISC BULGE AT L3-L4 WITH MILD CANAL STENOSIS. ON (B)(6) 2009: THE PATIENT UNDERWENT MR OF LUMBAR SPINE DUE TO LOW BACK PAIN. IMPRESSION: L4-5 AND L5-S1 LAMINECTOMY, DISCECTOMY, ANTERIOR POSTERIOR FUSION. L5-S1 SUSPECTED RECURRENT/RESIDUAL DISC PROTRUSION WHICH INVAGINATES THE ANTERIOR DURAL TUBE, HOWEVER DOES NOT APPEAR TO CAUSE SIGNIFICANT CENTRAL CANAL STENOSIS. L2-L3 AND L3-L4 MILD CENTRAL AND BILATERAL NEURAL CANAL STENOSIS SECONDARY TO BROAD BASED POSTERIOR DISC BULGES, LIGAMENTUM FLAVUM THICKENING AND FACET ARTHROPATHY. ON (B)(6) 2009: THE PATIENT UNDERWENT MRI OF LUMBAR SPINE. IMPRESSION: RECURRENT DISC PROTRUSION AT L5-S1 WITHOUT SIGNIFICANT CENTRAL CANAL STENOSIS. ON (B)(6) 2010: THE PATIENT UNDERWENT MRI OF LUMBAR SPINE DUE TO LOW BACK PAIN RADIATING TO LEGS. IMPRESSION: DEGENERATIVE DISC DISEASE. STATUS POST ANTERIOR POSTERIOR FUSION AT L4-L5 AND L5-S1. SPONDYLOSIS. ON (B)(6) 2013: THE PATIENT UNDERWENT MRI OF THE LUMBAR SPINE WITH AND WITHOUT CONTRAST DUE TO STATUS POST L3-S1 FUSION. IMPRESSION: STATUS POST L4 THROUGH S1 FUSION WITH GOOD ALIGNMENT OF THE FUSED VERTEBRAL BODIES. L5-S1 CENTRAL DISC HERNIATION AND DORSAL BONY RIDGE CAUSES COMPRESSION UPON THE THECAL SAC AND BILATERAL NEURAL FORAMINAL NARROWING. RIGHT SIDED NEURAL FORAMINAL NARROWING THE L4-L5 LEVEL SECONDARY TO RIGHT SIDED DORSAL BONY RIDGE. BILATERAL LATERAL RECESS NARROWING THE L2-L3 AND L3-L4 LEVELS. ON (B)(6) 2014: THE PATIENT UNDERWENT MRI OF THE LUMBAR SPINE WITH AND WITHOUT CONTRAST DUE TO CHRONIC LOW BACK PAIN. IMPRESSION: POST CENTRAL LAMINECTOMY L4-L5 AND L5-S1 WITH SURGICALLY PLACED DISC FUSION DEVICE AT BOTH LEVELS AND BILATERAL PEDICLE SCREW FUSION L4, L5 AND S1. RIGHT SIDED BONY RIDGING PRODUCING SEVERE RIGHT FORAMINAL STENOSIS L4-L5. SPONDYLITIC RIDGE L5-S1 EFFACING THE THECAL SAC EXTENDING TO THE INFERIOR PORTION OF BOTH NEURAL FORAMEN. MODERATE BILATERAL L5-S1 FORAMINAL STENOSIS. A 3MM BROAD BASED L2-L3, L3-L4 DISC BULGE. MODERATE L2-L3, L3-L4 FORAMINAL STENOSIS.
IT WAS REPORTED THAT ON (B)(6) 2008 THE PATIENT WAS ADMITTED TO THE FACILITY WHERE THE PATIENT UNDERWENT SPINE FUSION SURGERY USING RHBMP2 ON THE LUMBAR REGION OF SPINE FROM VERTEBRAE L4-S1. THE RHBMP-2 COLLAGEN SPONGE WAS USED TO FUSE MORE THAN ONE LEVEL OF THE SPINE. THE RHBMP-2 COLLAGEN SPONGE WAS PLACED OUTSIDE A CAGE. POST-OP, PATIENT REPORTEDLY HAD "PROGRESSIVELY WORSENING LOWER BACK PAIN, WITH PAIN RADIATING INTO HIS BUTTOCKS AND LEGS, AND ASSOCIATED NUMBNESS, TINGLING AND WEAKNESS IN HIS LEFT LOWER EXTREMITY". PATIENT CONTINUES TO EXPERIENCE CHRONIC LOWER BACK PAIN, WITH PAIN RADIATING TO HIS LEGS AND LEFT FOOT, NUMBNESS AND TINGLING IN HIS LEGS AND FEET, AND MUSCLE SPASMS IN HIS LEGS. PATIENT ALSO REPORTEDLY SUFFERS "EXTREME DIFFICULTY SLEEPING, BLADDER DYSFUNCTION, SEXUAL ISSUES, DEPRESSION, IS UNABLE TO SIT FOR EXTENDED PERIODS OR STAND FOR ANY LENGTH OF TIME, AND REQUIRES OCCASIONAL USE OF A CANE TO ASSIST WITH AMBULATION".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 50171 | 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 | Required Intervention |