APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Report
- Report Number
- 1030489-2019-01426
- Event Type
- Injury
- Date Received
- December 15, 2019
- Report Date
- February 20, 2020
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA, INC.
- Product Code
- KWP
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- 003
Narratives
ADDITIONAL INFORMATION: B5, B7, H10 H10: RADIOLOGICAL IMAGES REVIEW RESULTS: PRE-OP MRI, POST-OP X-RAYS FOR EXTENSIVE THORACO-LUMBAR FUSION WERE PROVIDED. POST-OP CT OF LUMBAR SPINE WAS ALSO PROVIDED ON CD. LEVELS INSTRUMENTED APPEARS TO BE T10-L4. ON X-RAY DATED (B)(6) 2018, A ROD FRACTURE IS PRESENT AT L3-L4 BILATERALLY. ON CT, BONE QUALITY APPEARS POOR. CEMENT AUGMENTATION IS PRESENT AT L2, L3, L4. FUSION ACROSS THE THORACIC FACETS APPEARS TO BE PRESENT. IT IS DIFFICULT TO ASSESS AT THE LOWER LEVELS. IT IS UNKNOWN WHAT TYPE OF ROD WAS USED. 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.
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.
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¿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 THAT ON: (B)(6) 2017: THE PATIENT PRESENTED FOR A FOLLOW-UP VISIT AND UNDERWENT X-RAY OF LUMBAR SPINE ¿ 2-3 VIEWS (AP AND LATERAL). IMPRESSION: MULTIPLE SPOT IMAGES OBTAINED DURING POSTERIOR FIXATION OF THE THORACOLUMBAR REGION. (B)(6) 2017: THE PATIENT PRESENTED FOR A FOLLOW-UP VISIT AND UNDERWENT X-RAY OF LUMBAR SPINE ¿ 2-3 VIEWS (AP AND LATERAL). IMPRESSION: POST-OP LUMBAR SPINE WITH MULTILEVEL THORACOLUMBAR FUSION. ADDITION OF LOWER LUMBAR FUSION HARDWARE RELATIVE TO THE EXAM OF (B)(6) 2017. L2-L4 VERTEBROPLASTIES RELATIVE TO PRIOR EXAMINATION. (B)(6) 2017: THE PATIENT CAME PRESENTED FOR A FOLLOW-UP VISIT AND UNDERWENT X-RAY OF LUMBAR SPINE ¿ 2-3 VIEWS (AP AND LATERAL). IMPR ESSION: THERE ARE 5 LUMBAR VERTEBRAL BODIES IDENTIFIED. AGAIN THERE IS HARDWARE IDENTIFIED IN THE THORACOLUMBAR SPINE EXTENDING FROM APPROXIMATELY T10 THROUGH THE L4 LEVEL. HARDWARE IS UNCHANGED IN POSITION. THERE IS SOME CEMENT AT MULTIPLE LEVELS OF THE PEDICLE SCREWS WHICH IS SEEN AT THE L2, L3 AND L4 LEVELS. THERE ARE ARTERIAL VASCULAR CALCIFICATIONS. THERE IS A FRACTURE NOTED OF THE T12 VERTEBRAL BODY WHICH APPEARS RELATIVELY UNCHANGED. THERE ARE SCATTERED DEGENERATIVE CHANGES THROUGHOUT THE SPINE. (B)(6) 2018: THE PATIENT PRESENTED FOR A FOLLOW-UP VISIT AND UNDERWENT X-RAY OF LUMBAR SPINE ¿ 2-3 VIEWS (AP AND LATERAL). IMPRESSION: STABLE POSTSURGICAL CHANGES FOLLOWING THORACOLUMBAR FUSION. (B)(6) 2018: THE PATIENT PRESENTED FOR A FOLLOW-UP VISIT AND UNDERWENT X-RAY OF LUMBAR SPINE ¿ 4 VIEWS (AP, LATERAL, AND LATERAL FLEXION AND EXTENSION. IMPRESSION: INTERVAL HARDWARE FRACTURE OF THE POSTERIOR RODS AT L3-L4. THE RESULT REPORTING OFFICE (F1) WILL COMPLETE APPROPRIATE FOLLOW-UP ACTIONS BASED ON DEFINED PROCESSES. (B)(6) 2018: THE PATIENT PRESENTED FOR A FOLLOW-UP VISIT AND UNDERWENT CT OF LUMBAR SPINE W/O IV CONTRAST. IMPRESSION: AGAIN IDENTIFIED IS HARDWARE FRACTURE OF THE POSTERIOR RODS AT L3-L4. EXTENSIVE CHRONIC AND POSTSURGICAL CHANGES AS DESCRIBED ABOVE. (B)(6) 2018: THE PATIENT PRESENTED FOR A FOLLOW-UP VISIT AND UNDERWENT MRI OF LUMBAR SPINE W/O IV CONTRAST. IMPRESSION: OLD T12 COMPRESSION FRACTURE. PRIOR LAMINECTOMIES AND EXTENSIVE POSTERIOR FUSION. THERE IS MULTILEVEL DEGENERATIVE CHANGE RESULTING IN MODERATELY SEVERE CENTRAL SPINAL CANAL STENOSIS AT L3-4, NO ACUTE FRACTURE OR SUBLUXATION IS SEEN.
IT WAS REPORTED THAT ON: (B)(6) 2017: THE PATIENT PRESENTED WITH FOLLOWING PRE-OPERATIVE DIAGNOSIS: 1) L2-L3, L3-L4 SPONDYLOSIS WITH SPINAL STENOSIS AND FORA MINAL STENOSIS. 2) JOINT INSTABILITY L2-L3 AND L3-L4. 3) POSTOPERATIVE SCAR TISSUE FROM PRIOR SURGERY. 4) PREVIOUS THORACOLUMBAR FUSION FOR T12 COMPRESSION FRACTURE. 5) SEVERE QUADRICEPS WEAKNESS. 6) FRACTURE OF THE SUPERIOR ENDPLATE OF L4. 7) DEGENERATIVE SCOLIOSIS BELOW THE PREVIOUS FIXATION. SHE UNDERWENT THE FOLLOWING PROCEDURES: 1) FIXATION OF HEAD IN MAYFIELD FIXATION DEVICE WITH PINS. 2) EXPLORATION OF PREVIOUS FUSION WITH REMOVAL OF THE SET SCREWS AND THE ROD. 3) L2-L3, L3-L4 LAMINECTOMY WITH PARTIAL 50% FACETECTOMY AND DECOMPRESSION OF SPINAL CANAL AND NEURAL FORMAMEN. 4) L2-L3 DISKECTOMY AND PERFORMANCE OF POSTERIOR LUMBAR INTERBODY FUSION. 5) PLACEMENT OF PEEK CAGE. 6) L2-L3 AND L3-L4 POSTEROLATERAL FUSION. 7) PLACEMENT OF PEDICLE SCREWS AT L2. L3 AND L4. 8) REDUCTION OF SCOLIOSIS AND FIXATION. 9) KYPHOPLASTY L3 AND L4. 10) INTRAOPERATIVE EVOKED POTENTIAL MONITORING, ELECTROMYOGRAM MONITORING. AS PER OP-NOTES, ¿USING A #10 KNIFE, AN INCISION WAS MADE THROUGH THE PREVIOUS SCAR TISSUE AND EXTENDED ABOUT 5-6 CM BELOW THAT. SOFT TISSUE WAS DISCARDED OFF THE PRIOR INSTRUMENTATION. THE CROSSLINK WAS REMOVED, FOLLOWED BY REMOVAL OF THE SET SCREWS AND REMOVAL OF THE RODS ON BOTH SIDES. THE FUSION APPEARED TO SOLIDIFY HEALED. SOFT TISSUE DISSECTED OFF THE LOWER PART OF THE FIXATION ALONG WITH THE T PIECES OF L2, L3 AND L4 BILATERALLY. THE LEVEL WAS AGAIN CONFIRMED ON THE X-RAYS. THE LEKSKELL RONGUER WAS USED TO REMOVE SPINOUS PROCESS OF L3 AND THE SUPERIOR HALF OF THE SPINOUS OF L4. A WIDE LAMINECTOMY WAS PERFORMED ALONG WITH REMOVAL OF SCAR TISSUE FROM THE AREA OF PRIOR SURGERY. SEVERE STENOSIS WAS NOTED AT THE L2-L3 AND L3-L4 LEVEL. AFTER COMPLETE DECOMPRESSION WITH REMOVAL OF THE PART OF THE MEDIAL FACETS AT THESE LEVELS, I PERFORMED A DISCECTOMY ON THE RIGHT AT L2-3 LEVEL. REMOVAL OF THE INTRADISC SOFT TISSUE WAS PERFORMED, FOLLOWED BY PACKING BONE ALONG THE ANTERIOR ASPECT OF THE DISK PACE. THIS WAS FOLLOWED BY AN 8MM CAGE EXPANDED TO 12MM. THE BACK OF THE CAGE WAS FILLED WITH BONE GRAFT. THE PHYSICIAN THEN PROBED THE PEDICLES OF L3 AND L4. THE L2 PEDICLE SCREWS WAS REMOVED SINCE IT APPEARED TO BE PROUD TO FACILITATE WITH RESTORATION OF LUMBAR LORDOSIS. THE FACET SCREW WAS DRILLED DOWN. THE PHYSICIAN PROBED THE PEDICLES OF L3 AND L4, TAPPED THE. CEMENT WAS MIXED AND CEMENT WAS INJECTED INTO THE VERTEBRAL BODY OF L2 AND L3 TO PREVENT ANY FURTHER PROGRESSION OF THE FRACTURE FOLLOWED BY PLACEMENT OF THE PEDICLE SCREWS. ONCE THE SCREWS WERE PLACED, THEY WERE STIMULATED AND ALL APPEARED TO STIMULATE AT GREATER THAN20 MILLIAMPS. THE PHYSICIAN THEN DECORTICATED THE BONE OVER THE T PIECES OF L1, L2 AND L3 ALONG WITH THE FACET JOINTS. BONE WAS PACKED OVER THIS AREA ALONG WITH 2 SPONGES OF PREVIOUS FUSION, AS WELL AS EXTEND DOWN TO L4. THE ROD WAS CONTOURED TO CONFORM WITH LUMBAR LORDOSIS AND THORACIC KYPHOSIS. THIS WAS THEN PLACED OVER THE TULIPS OF THE SET SCREWS. THIS WAS THEN PLACED OVER THE TULIPS OF THE SET SCREWS. IN SITU BENDING OF ROD WAS PERFORMED TO CORRECT THE SAGITTAL AND CORONAL DEFORMITY. AFTER THE SET SCREWS WERE ALL PLACED, X-RAY SHOWED SATISFACTORY CORRECTION OF THE CORONAL DEFORMITY AND GO OD RESTORATION OF LUMBAR LORDOSIS. THE SET SCREWS WERE TIGHTENED TO THE APPROPRIATE PRESSURE. A CROSS LINK WAS PLACED AT 2 LEVELS. THIS PRODUCED EXCELLENT CORRECTION OF THE CORONAL AND SAGITTAL DEFORMITY. ADDITIONAL BONE GRAFT WAS THEN PACKED LATERAL TO THE ROD OVER THE L1-L2, L2-L3 AND L3-L4 LEVELS. A PIECE OF GELFOAM WAS LAID OVER THE AREA OF THE DECOMPRESSION. THE SPINAL CANAL APPEARED TO BE WELL DECOMPRESSED.¿ NO INTRA-OP COMPLICATIONS WERE REPORTED. (B)(6) 2017: THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. (B)(6) 2018: THE PATIENT UNDERWENT PHYSICAL EXAMINATION. THE ASSESSMENT SHOWED THAT SHE WAS DOING WELL FOLLOWING HER SURGERY. THERE WAS GOOD RELIEF OF HER BACK PAIN AND LEG PAIN. HER INCISION WAS WELL HEALED. SHE WISHED TO RETURN TO WORK THIS WEEK. X-RAYS WERE SATISFACTORY.
PATIENT HEIGHT- 64¿ (1.626 M) (B)(6) 2017: INCLUSION TO PREVIOUS OP-NOTES "BONE WAS PACKED OVER THIS AREA ALONG WITH 2 SPONGES OF RHBMP2 TO AUGMENT THE FUSION. A LONGER ROD WAS CUT TO FIT OVER THE PREVIOUS FUSION, AS WELL AS EXTEND DOWN TO L4. " (B)(6) 2017: THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. (B)(6) 2018: THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. (B)(6) 2019: THE PATIENT WAS ADMITTED TO THE FACILITY FOR HEALTH CHECK-UP AND GOT DISCHARGED ON (B)(6) 2019.
PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. X-RAY IMAGE REVIEW RESULTS: POST-OP CT FOR THORACO-LUMBAR FUSION WERE PROVIDED. ON ONE OF THE CORONAL CT IMAGES, IT APPEARS THAT THE RODS ARE BROKEN BILATERALLY. IT IS UNCLEAR WHAT LEVEL THIS OCCURRED AT. THE TIME FROM SURGERY AND FUSION STATUS IS UNKNOWN. THE OTHER PROVIDED IMAGES ARE OF INSUFFICIENT QUALITY TO JUDGE. THE MANUFACTURER FOR THE BROKEN RODS IS NOT KNOWN YET. ADDITIONALLY, PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN WHICH OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2017 DUE TO LUMBAR SPONDYLOSIS AND COMPRESSION FRACTURE. ON AN UNKNOWN DATE IN (B)(6) 2017, THE PATIENT UNDERWENT A BACK FUSION SURGERY, WITH THE HELP OF SCREWS, RODS, CEMENT, GRAFTS AND CROSSLINKS. THE PATIENT WAS DISCHARGED FROM THE FACILITY ON (B)(6) 2017. ON AN UNKNOWN DATE, REPORTEDLY 6 MONTHS POST-OP, THE RODS BROKE BILATERALLY. THE PATIENT ALSO COMPLAINED OF PAIN IN BACK/SPINE. REPORTEDLY, THE SURGEON TOLD THE PATIENT THAT THE BROKEN RODS WERE NOT CAUSING THE PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1265595 | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | KWP | MEDTRONIC SOFAMOR DANEK USA, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | PEEK CAGE, SCREWS, CROSSLINK. |