CD HORIZON SPINAL SYSTEM
Report
- Report Number
- 1030489-2019-00364
- Event Type
- Injury
- Date Received
- March 31, 2019
- Report Date
- September 5, 2019
- Manufacturer
- WARSAW ORTHOPEDICS
- Product Code
- KWP
- PMA / PMN Number
- K113174
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- 003
Narratives
MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. 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 INFORMATION: PATIENT IDENTIFIER, AGE OR DATE OF BIRTH, SEX, EVENT, RELEVANT TESTS/LABORATORY DATA, OTHER RELEVANT HISTORY, BRAND NAME, MANUFACTURER NAME, CITY AND STATE,AND PMA/510K.MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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.
IT WAS REPORTED PER PATIENT'S MEDICAL RECORDS THAT ON: (B)(6) 2017: THE PATIENT UNDERWENT XR LUMBAR SPINE AP AND LATERAL. IMPRESSIONS: THERE IS A POSTERIOR AND INTERVERTEBRAL FUSION AT L4-5. THE SURGICAL HARDWARE APPEARS INTACT. A SURGICAL DRAIN IS NOTED. NO COMPLICATING FEATURES IDENTIFIED. (B)(6) 2017: PATIENT UNDERWENT 6 WEEKS FOLLOW UP WITH STATUS POST L3-5 FUSION WITH TLIF L4-5. IMPRESSIONS: LUMBAR X-RAYS REVIEWED, INTACT GRAFT AND INSTRUMENTATION. (B)(6) 2017: PATIENT CAME FOR FOLLOW UP. RADIOLOGY: MRI LUMBAR SPINE REVIEWED BY ME DEMONSTRATING SYNOVIAL CYST FORMATION L3-4 WITH SIGNIFICANT FACET ARTHROPATHY L3-4 AS WELL AS STENOSIS AT L5-S1 AND STENOSIS AT L2-3 CT SCAN LUMBAR SPINE SHOWS GOOD INTACT INSTRUMENTATION WITH EVIDENCE OF FACET ARTHROPATHY L3-4 AS WELL AS CORONAL DEFORMITY AND LOSS OF NORMAL LORDOSIS WITH AN APEX AT L3. THE PATIENT PRESENTED WITH THE FOLLOWING PRE-OP DIAGNOSIS: 1. JUNCTIONAL STENOSIS IN THE LUMBAR SPINE. 2. LUMBAR DEGENERATIVE SCOLIOSIS. 3. SYNOVIAL CYST. THE PATIENT UNDERWENT FOLLOWING PROCEDURES: DIRECT LATERAL INTERBODY FUSION AT L2-L3, L3-L4 WITH PEEK INTERBODY ALLOGRAFT AND NEURO MONITORING POSTERIOR REVISION WITH REINSERTION OF LUMBAR INSTRUMENTATION, L3-L4 LAMINECTOMY FOR RESECTION OF SYNOVIAL CYST, L2-PELVIS FUSION WITH AUTOGRAFT, POSTERIOR INSTRUMENTATION AND NEURO MONITORING WITH O-ARM/STEALTH APPROACH. AS PER OPERATIVE NOTES, ¿I PREPARED THE ENDPLATES APPROPRIATELY, WITH ASSISTANCE FROM THE MID-LEVEL PROVIDER PROVIDING SOFT TISSUE RETRACTION AND NEURAL STRUCTURE RETRACTION AS NEEDED. I ALSO PERFORMED A CONTRALATERAL RELEASE. I THEN PLACED VARIOUS SIZES OF INTERBODY TEMPLATES AND DECIDED TO PLACE A 12 MILLIMETER BY 50-MILLIMETER GRAFT. I COPIOUSLY IRRIGATED THE DISC SPACE. I CONFIRMED ADEQUATE PREPARATION OF THE DISC SPACE AND TOOK A PEEK GRAFT WITH A SMALL AMOUNT OF BONE MORPHOGENIC PROTEIN AND BONE GRAFT. WITH THE ASSISTANCE OF THE MID-LEVEL PROVIDER PROVIDING IMPORTANT SOFT TISSUE RETRACTION, I IMPLANTED THIS UNDER FLUOROSCOPIC GUIDANCE AND REMOVED THE APPLICATOR. THE GRAFT WAS IN SATISFACTORY POSITION. I COPIOUSLY IRRIGATED WITH ANTIBIOTIC IRRIGATION. THE ANCHORING PEN WAS THEN REMOVED, AND THE TUBULAR RETRACTOR REMOVED. I INSPECTED THE RETROPERITONEAL ON REMOVING THE RETRACTOR. NO OBVIOUS INTRA-ABDOMINAL OR RETROPERITONEAL INJURIES. I THEN PLACED DEEP SELF-RETAINING RETRACTORS. I STARTED BY PLACING BILATERAL PELVIC SCREWS. MY MID-LEVEL AND I PLACED THE BILATERAL PELVIC SCREWS UNDER STEALTH GUIDANCE USING 8.5 BY 90 MILLIMETER SCREWS. I THEN FOCUSED MY ATTENTION ON PEDICLE SCREWS. I DECIDED TO PLACE BILATERAL SCREWS AT L2, L3. I USED 6.5 MILLIMETER SCREWS. I LEFT THE L4 AND L5 SCREWS AND PLACED. THE MID-LEVEL PROVIDER ASSISTED ME AND PLACING ALL THE INSTRUMENTATION WITH BOTH HANDLING OF THE INSTRUMENTATION AS WELL AS RETRACTION OF SOFT TISSUE. I TESTED EACH SCREW WITH EMG WITH THRESHOLDS ABOVE THE ACCEPTED MINIMAL. I THEN COPIOUSLY IRRIGATED WITH ANTIBIOTIC IRRIGATION. THE EXPOSED BONY SURFACES OF THE FACET JOINTS AND PROXIMAL TRANSVERSE PROCESSES WERE ALREADY DECORTICATED DURING THE LAMINECTOMY IN PREPARATION FOR THE ARTHRODESIS. I TOOK 2 PRECUT RODS PLACED THE APPROPRIATE AMOUNT OF CURVATURE AND AFFIX THEM TO THE PEDICLE SCREWS USING SET SCREWS. I USED INTERCONNECTORS FOR THE PELVIC INSTRUMENTATION. A CROSS-LINK X2 WAS ALSO PLACED. THE MID-LEVEL PROVIDER BROKE THE HEADS OF THE SET SCREWS OFF. I THEN REMOVED THE SELF-RETAINING RETRACTORS." NO PATIENT COMPLICATIONS WERE REPORTED. (B)(6) 2019: THE PATIENT PRESENTED WITH THE FOLLOWING PRE-OP DIAGNOSIS: 1. SPINAL INSTABILITIES OF LUMBOSACRAL REGION. 2. ACUTE LOW BACK PAIN, UNSPECIFIED BACK PAIN LATERALLY, WITH SCIATICA PRESENCE UNSPECIFIED. 3. SPINAL STENOSIS. THE PATIENT UNDERWENT FOLLOWING PROCEDURES: REMOVAL OF POSTERIOR LUMBAR PELVIC INSTRUMENTATION, L1-L2 DECOMPRESSIVE LAMINECTOMY, FORAMINOTOMY, LUMBAR 1- LUMBAR 3 POSTERIOR FUSION WITH POSTERIOR INSTRUMENTATION, AUTOGRAFT AND INTRAOPERATIVE NEUROMONITORING. AS PER OPERATIVE NOTES, ¿I EXPOSED LATERALLY TO THE POSTERIOR INSTRUMENTATION AND EXPOSED THIS IN ITS ENTIRETY FROM L2 TO PELVIS. I THEN USED THE APPROPRIATE REMOVAL SYSTEM AND REMOVED THE SET SCREWS FOLLOWED BY THE RODS. THE MID-LEVEL PROVIDER ASSISTED WITH ALL INSTRUMENTATION HANDLING AND REMOVAL. I THEN REMOVED THE PEDICLE SCREWS AT THE L4 AND L5 LEVELS AS WELL AS THE PELVIC SCREWS. THE LEFT-SIDED ROD WAS NOTED TO BE FRACTURED JUST PROXIMAL TO THE PELVIC INTERCONNECTORS. AT THIS POINT I USED A HIGH-SPEED DRILL TO DRILL THE LAMINA AND MEDIAL FACETS OF THE LEVEL ROSTRAL TO THE INSTRUMENTATION AT L1-2. THERE WAS CLEAR-CUT INSTABILITY AT L1-2. I COMPLETED THIS BONY WORK USING A KERRISON RONGEUR. I THEN FOCUSED ON POSTERIOR LATERAL INSTRUMENTATION. I PLACED PEDICLE SCREWS AT L1. I USED INSTRUMENTATION. I PLACED THE PEDICLE SCREWS UNDER FLUOROSCOPIC GUIDANCE. I THEN STIMULATED THE SCREWS WITH EMG TO MAKE SURE THERE WAS NO ABNORMAL NERVE STIMULATION. I THEN TOOK 2 PRECUT PRE-BENT COBALT CHROME RODS AND AFFIX THEM TO THE L1, L2 AND L3 PEDICLE SCREWS USING SET SCREWS. I THEN BROKE THE HEADS OF THE SET SCREWS WITH THE TORQUE COUNTER TORQUE DEVICE. I THEN IRRIGATED ONCE MORE. I THEN TOOK LOCALLY HARVESTED AUTOLOGOUS BONE GRAFT COMBINED WITH A SMALL AMOUNT OF VANCOMYCIN POWDER AND PLACED IT OVER THE DECORTICATED SURFACES FROM L1 TO L3." NO INTRA-OPERATIVE COMPLICATIONS WERE REPORTED.
IT WAS REPORTED THAT ON: (B)(6)2017: PATIENT UNDERWENT 6 WEEKS FOLLOW UP WITH CT OF THE LUMBAR SPINE. IMPRESSIONS: CLEAR-CUT SYMPTOMS OF NEUROGENIC CLAUDICATION. PAIN WAS 6 OUT OF 10 ON THE VAS SCALE. HE DID HAVE NUMBNESS IN THE BALLS OF THE BILATERAL FEET. HE ALSO HAD GAIT INSTABILITY. NEUROLOGICAL: WEAKNESS IN ARMS/LEGS BUT DENIED DIZZINESS/FAINTING AND DENIED STROKE/TIA. MUSCULOSKELETAL: JOINT PAIN/SWELLING AND LOW BACK PAIN BUT DENIED RHEUMATOID ARTHRITIS. RESULTS: MRI LUMBAR SPINE DEMONSTRATED SIGNIFICANT STENOSIS L3-4 AND L4-5 WITH SEVERE DEGENERATIVE DISC DISEASE L4-5. CT LUMBAR SPINE DEMONSTRATED SEVERE DEGENERATIVE DISC AT L4-5, MULTILEVEL FACET ARTHROPATHY WORSE AT L4. ACTIVE PROBLEMS: 1. CELLULITIS OF TOE OF LEFT FOOT. 2. CHONDROMALACIA OF RIGHT KNEE. 3. CHRONIC OBSTRUCTIVE PULMONARY DISEASE. 4. FOOT PAIN. 5. GASTROCNEMIUS EQUINUS OF RIGHT LOWER EXTREMITY. 6. GENERALIZED PAIN. 7. GOUT. 8. HIGH TRIGLYCERIDES. 9. HYPERTENSION. 10. INGROWN NAIL. 11. KNEE PAIN. 12. METATARSALGIA. 13. ONYCHOMYCOSIS .14. PAIN, LOW BACK. 15. POSTERIOR TIBIAL TENDINITIS, RIGH T. 16. PRE-OPERATIVE CLEARANCE. 17. PTTD (POSTERIOR TIBIAL TENDON DYSFUNCTION. 18. RIGHT KNEE PAIN. 19. SHINGLES. 20. SPINAL STENOSIS, LUMBAR. 21. TEAR OF LATERAL MENISCUS OF RIGHT KNEE. 22. WHEEZING. 03 APR 2017: THE PATIENT WAS ADMITTED. THE PATIENT PRESENTED WITH THE FOLLOWING PRE-OPERATIVE DIAGNOSIS: 1. SPINAL STENOSIS OF LUMBAR REGION. 2. DEGENERATION OF LUMBAR OR LUMBOSACRAL INTERVERTEBRAL DISC. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: LUMBAR LAMINECTOMY WITH FORAMINOTOMIES L3-L5; TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L4-L5 WITH PEEK INTERBODY GRAFT; OPEN LUMBAR FUSION L4-L5 WITH POSTERIOR INSTRUMENTATION, AUTOGRAFT AND INTRAOPERATIVE NERVE MONITORING. AS PER SURGEON'S OPERATIVE NOTES, ¿... I THEN BEGAN MY DISCECTOMY WITH A PITUITARY RONGEUR FOLLOWED BY CURETTES. I DID AN EXTENSIVE DISCECTOMY. I PREPARED THE ENDPLATES WITH DISC SPACE SHAVERS. I DECIDED TO USE A PEEK EXPANDABLE INTERBODY CAGE. I PLACED LOCALLY HARVESTED AUTOLOGOUS BONE GRAFT INTO THE DISC SPACE FOLLOWED BY THE EXPANDABLE CAGE. I EXPANDED THE CAGE TO ITS FULL HEIGHT. I THEN PLACED LOCALLY HARVESTED AUTOLOGOUS BONE GRAFT INTO THE GRAFT. I THEN COPIOUSLY IRRIGATED WITH ANTIBIOTIC IRRIGATION. THE MID-LEVEL PROVIDER ASSISTED ME WITH INTERBODY GRAFT PLACEMENT. I THEN FOCUSED ON POSTERIOR LATERAL INSTRUMENTATION. I PLACED PEDICLE SCREWS FROM L4 TO L5. I USED INSTRUMENTATION. I PLACED THE PE DICLE SCREWS UNDER FLUOROSCOPIC GUIDANCE. I THEN STIMULATED THE SCREWS WITH EMG TO MAKE SURE THERE WAS NO ABNORMAL NERVE STIMULATION. I THEN TOOK 2 PRECUT PRE-BENT COBALT CHROME RODS AND AFFIXED THEM TO THE PEDICLE SCREWS USING SET SCREWS. I THEN BROKE THE HEADS OF THE SET SCREWS WITH THE TORQUE COUNTER TORQUE DEVICE. I THEN IRRIGATED ONCE MORE. THE MID-LEVEL PROVIDER AND I THEN TOOK LOCALLY H ARVESTED AUTOLOGOUS BONE GRAFT COMBINED WITH A SMALL AMOUNT OF VANCOMYCIN POWDER AND PLACED IT OVER THE DECORTICATED SURFACES FROM L4 TO L5, FOR ARTHRODESIS.¿ (B)(6)2017: THE PATIENT WAS DISCHARGED.
ONLY YEAR VALID. DATE AND MONTH OF IMPLANT ARE UNKNOWN. H6: 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
RADIOLOGICAL IMAGES REVIEW: POST-OPERATIVE CT/MR AND POST OP REVISION CT PROVIDED FOR L2-ILIAC FUSION. ON PRE-OP IMAGES, THERE IS AN L4-5 STENOSIS WITHOUT LEVEL DEFORMITY. ON THE POST REVIEW CT, A ROD FRACTURE IS EVIDENT ON THE LEFT SIDE AT L5-S1. INTERBODY GRAFTS ARE PRESENT AT L2-L3, L3-L4, L4-L5 WITH VARYING DEGREES OF BONY GROWTH. THERE IS NO OBVIOUS LATERAL FUSION MASS ANYWHERE ELSE AND WITHOUT BONY FUSION AT LUMBOSACRAL JUNCTION, THIS IS A LIKELY POINT FOR HARDWARE FAILURE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THROUGH LEGAL THAT ON UNKNOWN DATE, POST-OP, THE ROD FRACTURED INSIDE THE PATIENT. ALLEGEDLY, THE PATIENT ALSO EXPERIENCED INJURY DUE TO THIS EVENT; AND UNDERWENT A REVISION SURGERY FOR REMOVAL OF THE IMPLANTED ROD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 261185 | CD HORIZON SPINAL SYSTEM | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | KWP | WARSAW ORTHOPEDICS | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |