CD HORIZON SPINAL SYSTEM
Report
- Report Number
- 1030489-2013-00859
- Event Type
- Injury
- Date Received
- March 26, 2013
- Date of Event
- September 17, 2012
- Report Date
- April 25, 2016
- Manufacturer
- MEDTRONIC SOFAMOR DANEK
- Product Code
- KWP
- PMA / PMN Number
- UNKNOWN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- ATTORNEY
Narratives
(B)(6). (B)(4). NEITHER DEVICE NOR APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION.
(B)(4).
IT WAS REPORTED THAT THE PT. UNDERWENT A PEDICLE SUBTRACTION OSTEOTOMY AND SPINAL FUSION T11 - PELVIS WITH QUARTER INCH STAINLESS STEEL HARDWARE. AT AN UNKNOWN TIME POST-OP THE PT. PRESENTED WITH WOUND DRAINAGE THAT WAS INITIALLY THOUGHT TO BE SUPERFICIAL WHEN A LOCAL EXCISION OF TISSUE AND WOUND VAC WAS DONE, BUT THE PT. CONTINUED TO DRAIN. AT 54 MONTHS POST-OP THE PT. UNDERWENT HARDWARE DEBRIDEMENT OF THE BACK. AT 60 MONTHS POST-OP THE PT. PRESENTED FOR ADDITIONAL SURGERY WITH SPINAL STENOSIS, FLAT BACK DEFORMITY, NONUNION, AND DRAINAGE FROM THE LUMBAR INCISION. PROCEDURE WAS TO REMOVE POSTERIOR INSTRUMENTATION, EXPLORATION OF FUSION, RE-INSTRUMENTATION WITH FUSION T11-PELVIS. ONCE THE MIDLINE BACK INCISION WAS MADE, A 'LITTLE' SUPERFICIAL POCKET OF PUS WAS DISCOVERED. ONCE COMPLETELY OPEN, A SIGNIFICANT AMOUNT OF METAL DEBRIS, BLACK TISSUE, A SIGNIFICANT AMOUNT OF SCARRING AND INFLAMMATORY TISSUE WAS DISCOVERED. NO DEEP PUS WAS VISIBLE. ONCE THE INSTRUMENTATION WAS EXPOSED, IT WAS NOTED THAT EVERY LOCKING CAP WAS LOOSE AS WELL AS SOME OF THE SCREWS. THE RIGHT ILIAC SCREW WAS NOTED TO BE BROKEN DOWN UNDER THE CREST. THE SURGEON DID NOT ATTEMPT TO REMOVE THIS SCREW. L1 SCREW WAS NOT REMOVED BECAUSE IT LOOKED FUSED. OTHER SCREWS WERE REMOVED AND REPLACED WITH LARGER DIAMETERS. AT THE TIME OF DISCHARGE, ALL INTRAOPERATIVE CULTURES WERE NEGATIVE.
IT WAS REPORTED THAT ON (B)(6) 2007, THE PATIENT UNDERWENT A SPINAL SURGERY WHICH INCLUDED A T11 TO S1 BILATERAL POSTEROLATERAL FUSION. ON (B)(6) 2012, THE PATIENT WAS REQUIRED TO UNDERGO A REVISION SURGERY WHICH INCLUDING REMOVAL OF THE HARDWARE AS WELL AS RE-INSTRUMENTATION AND A FUSION FROM T11 TO THE PELVIS. DURING THE SURGERY, AMONG OTHER THINGS, IT WAS FOUND THAT METAL DEBRIS AND BLACK TISSUE WERE PRESENT, ALL OF THE LOCKING CAPS AND SOME OF THE SCREWS WERE LOOSE, AND THE RIGHT ILIAC SCREW WAS BROKEN SIGNIFICANTLY UNDER THE CREST. AS A RESULT OF HIS INJURIES RESULTING FROM THE DEFECTIVE COMPONENTS, THE PATIENT HAS SUSTAINED SIGNIFICANT PAIN AND SUFFERING. ADDITIONALLY IT WAS REPORTED THAT ON: (B)(6) 2012: PATIENT PRESENTED WITH BACK SWELLING OF THE LOWER EDGE OF THE BACK INSTRUMENTATION WITH THE FOLLOWING SYMPTOMS PAIN AND SWELLING IN THE LAST 2 MONTHS. THE AREA HAS SWOLLEN ERYTHEMA AND INDURATION. HE NOTED NO PRIOR TRAUMA OR OTHER ANTECEDENT EVENT. COLONOSCOPY 2 YEARS AGO HAS BEEN MORE PROBLEMATIC AND ASPIRATION BY PCP WAS UNSUCCESSFUL. HE HAS NOTED MORE PROBLEMS WITH URINATION THAT ARE THOUGHT TO BE DUE SPINAL CORD DISORDER RATHER A UROLOGIC CAUSE. CURRENT THERAPY WHICH HAS INCLUDED OBSERVATION AND SHORT COURSE OF ANTIBIOTIC THERAPY HAS NOT OFFERED SIGNIFICANT IMPROVEMENT. THE PATIENT PRESENTS TO DISCUSS TREATMENT OPTIONS. NEUROLOGIC: HEADACHES, PARESTHESIA, COORDINATION PROBLEMS AND WEAKNESS. MUSCULOSKELETAL: BACK PAIN. (B)(6) 2012 PATIENT PRESENTED WITH THE DIAGNOSIS OF SOFT TISSUE, LUMBAR, BIOPSY: FIBROCONNECTIVE TISSUE SHOWING MODERATE TO SEVERE ACUTE AND CHRONIC INFLAMMATION, FOREIGN BODY-TYPE GIANT CELL REACTION, PIGMENL-LADEN HISTIOCYTES, AND GRANULATION FORMATION, SOFT TISSUE, LUMBER, EXCISION, SKIN AND FIBROADIPOSE TISSUE SHOWING FOCAL ACUTE AND CHRONIC INFLAMMATION WITH MICROABSCESSES, FOREIGN BODY-TYPE GIANT CELL REACTION, PIGMENT-LADEN HISTOCYTES, AND GRANULATION FORMATION (B)(6) 2012 THE PATIENT PRESENTED FOR EXCISION AND REMOVAL OF INSTRUMENTATION, EXPLANTED INSTRUMENTATION. SEGMENTS OF HYALINIZED FIBRO US TISSUE, DYSTROPHIC CALCIFICATION AND HISTOCYTES. (B)(6) 2012 THE PATIENT WITH THE FOLLOWING OPERATIVE PROCEDURES: 1. REMOVAL OF SEGMENTAL SPINAL INSTRUMENTATION. 2. EXPLORATION OF FUSION. 3. RE-INSTRUMENTATION T11 TO THE PELVIS. 4. FUSION T11 TO THE PELVIS. 5. LOCAL AUTOGENOUS BONE, 2 LARGE KITS OF BONE MORPHOGENIC PROTEIN AND 20 ML OF BONE GRAFT FOR FUSION. HE HAD A SIGNIFICANT AMOUNT OF METAL DEBRIS, A LOT OF BLACK TISSUE, A SIGNIFICANT AMOUNT OF SCARRING AND INFLAMMATORY TISSUE. THE DEEP CULTURES WERE TAKEN ANYWAYS. THE INSTRUMENTATION WAS EXPOSED. THIS WAS A VERY DIFFICULT EXPOSURE SCARRING. ONCE THE INSTRUMENTATION WAS EXPOSED, IT WAS NOTED THAT EVERY LOCKING CAP WAS LOOSE AS WELL AS SOME OF THE SCREWS. THE ROD WAS THEN REMOVED. THE ONLY THING THAT WAS LEFT WAS THE RIGHT ILIAC SCREW WHICH HAD BROKEN SIGNIFICANTLY DOWN UNDER THE CREST AND THE SURGEON THOUGHT THAT IT WOULD BE PRUDENT TO TRY AND GET THAT OUT. THE SCREWS WERE THEN REMOVED. IT DID APPEAR THAT HE WAS FUSED IN THE THORACIC SPINE. A SIGNIFICANT AMOUNT OF LOOSING ON THE RIGHT-HAND SIDE AS SCREWS WERE THEN UPSIZED. ALL SCREWS HAD AN EXCELLENT PURCHASE. AP AND LATERAL SHOWED GOOD POSITION OF ALL THE SCREWS. THE WOUND WAS COPIOUSLY IRRIGATED THROUGHOUT THE CASE. DECORTICATION WAS THEN PERFORMED WITH A HIGH-SPEED #5 FLUTED BALL BURR FROM T11 DOWN TO THE PELVIS. TWO LARGE KITS OF BONE MORPHOGENIC PROTEIN AND 20 ML OF BONE GRAFT WERE PLACED. THIS WAS AFTER FINAL TORQUING. THE MUSCLE WAS DEBRIDED. THE VANCOMYCIN POWDER OF APPROXIMATELY A GRAM AND HALF WAS PLACED DEEP IN THE WOUND. A HEMOVAC DRAIN WAS PLACED. FASCIA WAS THEN REAPPROXIMATED WITH #1, SUBCUTANEOUS TISSUE WITH 2-0 AND SKIN WITH 3-0 MONOCRYL. STERI-STRIPS WERE PLACED. DRY STERILE DRESSINGS APPLIED. IT SHOULD BE NOTED THAT THE REMAINING VANCOMYCIN POWDER WAS ON HE TOP OF THE FASCIA BELOW THE SUBCUTANEOUS CLOSURE. THE PATIENT WAS PLACED SUPINE ON HIS HOSPITAL BED, EXTUBATED AND TAKEN TO RECOVERY ROOM IN STABLE CONDITION. ON (B)(6) 2012 PATIENT PRESENTED FOR A FOLLOW UP EXAMINATION AND EVALUATION OF LOWER BACK SWELLING ON (B)(6) 2012 PATIENT PRESENTED FOR FOLLOW UP AND REPORTED IN THE BACK AND RADIATING DOWN HIS BUTTOCK AND POSTERIOR UPPER LEG. ON (B)(6) 2012 PATIENT PRESENTED FOR A FOLLOW UP EXAMINATION AND EVALUATION OF BACK WOUND. ON (B)(6) 2012 PATIENT PRESENTED FOR A FOLLOW UP EXAMINATION AND EVALUATION OF BACK WOUND. ON (B)(6) 2012 PATIENT PRESENTED FOR A FOLLOW UP EXAMINATION AND EVALUATION OF BACK WOUND. ON (B)(6) 2012 PATIENT PRESENTED FOR A FOLLOW UP EXAMINATION AND EVALUATION OF BACK WOUND. ON (B)(6) 2012 PATIENT PRESENTED FOR A FOLLOW UP EXAMINATION AND EVALUATION OF BACK WOUND.
IT WAS REPORTED THAT ON: (B)(6) 2007: PATIENT UNDERWENT 1) L1 TO L5 LAMINECTOMY WITH MEDIAL FACETECTOMIES OF L1- 2; L2-3, L3-4, L4-5, L5-S1 AND FORAMINOTOMIES OF THE L1- 2-3-4-5 AND S1 NERVE ROOTS; L2-3, L3-4 SMITH-PETERSON OSTEOTOMY; PARTIAL L3 CORPECTOMY; T11 TO S1 SEGMENTAL SPINAL INSTRUMENTATION ;T11 TO S1 BILATERAL POSTEROLATERAL FUSION; BILATERAL ILIAC FIXATION; LOCAL AUTOGENOUS BONE FOR FUSION. SURGERY. PRE-OP DIAGNOSIS: 1. SPINAL STENOSIS, 2. FLATBACK DEFORMITY. AS PER OP-NOTES, THE FACET CAPSULES WERE REMOVED. PEDICLE SCREWS WERE THEN PLACED. THESE WERE 6.5 X 40 IN THE THORACIC SPINE. THEY WERE 6.5 X 50 IN THE LUMBAR SPINE, ALL EXCEPT THE L1-L2 AND L5 ON THE RIGHT-HAND SIDE. THESE WERE 1/4 INCH RODS. THE ILIAC WING SCREWS WERE PLACED. THEY WERE 7.5 X 80. SCREWS WERE CHECKED UNDER X-RAY, AP AND LATERAL, AND FELT TO BE IN GOOD POSITION. THERE WAS A TROUGH CUT IN THE LAMINA-FACET JUNCTION FROM L1 TO L5. THE LAMINA AND SPINOUS PROCESS OF L1, L2, L3, L4, AND L5 WERE REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED. (B)(6) 2007: PATIENT PRESENTED FOR AP AND LATERAL VIEWS OF LUMBAR SPINE WERE OBTAINED. IMPRESSION: INTERVAL PLACEMENT OF VERTICAL CONNECTING RODS THROUGH EXTENSIVE POSTERIOR FUSION OF THE LOWER THORACIC AND LUMBAR SPINE WITHOUT EVIDENCE OF FRACTURE. PATIENT PRESENTED FOR AP AND CONE DOWN VIEWS OF LUMBAR SPINE WERE OBTAINED. IMPRESSION: BILATERAL PEDICLE SCREWS AT MULTILEVEL IN THE THORACIC AND LUMBAR SPINE. EXTENSIVE DEGENERATIVE CHANGES PRESENT. PATIENT PRESENTED FOR SINGLE LATERAL VIEW. IMPRESSION: LIMITED EXAM: EXTENSIVE MULTI-LEVEL DEGENERATIVE CHANGES THROUGHOUT THE LUMBAR SPINE. METALLIC MARKERS OVERLIE THE POSTERIOR ELEMENTS OF L2 AND L5. PATIENT PRESENTED DUE TO CHEST PAIN USING THE SINGLE PORTABLE AP UPRIGHT VIEW OF THE CHEST TECHNIQUE. IMPRESSION: ET TUBE IN PLACE WITH TIP 2CM FROM CARINA, LUNGS CLEAR, HEART NOT ENLARGED. (B)(6) 2007 THE PATIENT UNDERWENT CT OF ABDOMEN AND PELVIS WITH AND WITHOUT CONTRAST. IMPRESSION: THORACOLUMBAR FUSION CHANGES, SECONDARY LIMITED EXAMINATION. POST SURGICAL CHANGES. NO OBVIOUS LARGE HEMATOMA WAS SEEN. THE PATIENT UNDERWENT CTA OF CHEST WITH AND WITHOUT CONTRAST. IMPRESSION. INCIDENTAL FINDINGS. QUESTION SPINAL CANAL STENOSIS. NO EVIDENCE OF PULMONARY EMBOLISM. HOWEVER, EVALUATION WAS SLIGHTLY LIMITED. IF SIGNS AND SYMPTOMS PERSIST AND CLINICAL SUSPICION WARRANTS, FURTHER EVALUATION WITH VENTILATION/PERFUSION NUCLEAR MEDICINE SCAN MAY BE PERFORMED. (B)(6) 2007 THE PATIENT UNDERWENT SCOLIOSIS STUDY EXAM. IMPRESSION: PATIENT STATUS POST THORACOLUMBAR SACROILIAC SPINAL FUSION. NO COMPRESSION FRACTURE OR SPONDYLOLISTHESIS. THE PATIENT PRESENTED WITH FOLLOWING PREOPERATIVE DIAGNOSIS OF 1. ACUTE URINARY RETENTION. 2.BPH 3.HEMATURIA. THE PATIENT UNDERWENT CYSTOSCOPY.
IT WAS REPORTED THAT ON: (B)(6) 2007:PATIENT PRESENTED FOR POST-OP FOLLOW-UP. ON (B)(6) 2008:PATIENT PRESENTED FOR POST-OP FOLLOW-UP. PATIENT REPORTED INCREASED PAIN IN RIGHT BUTTOCK. AP LATERAL SCOLIOSIS FILMS SHOW HIM TO BE INSTRUMENTED FROM T11 TO THE SACRUM. HE DOES HAVE VERY GOOD SAGITTAL AND CORONAL BALANCE. HE DOES HAVE A BROKEN ILIAC WING SCREW ON THE RIGHT THE REST OF THE INSTRUMENTATION IS INTACT. IT LOOKS LIKE HE IS LAYING DOWN POSTEROLATERAL BONE. ON (B)(6) 2008:PATIENT PRESENTED FOR UNSCHEDULED FOLLOW-UP VISIT. PATIENT REPORTED HEARING A POP IN BACK TEN DAYS AGO AND HAD INCREASED PAIN IN LOW BACK, BUTTOCKS AND OCCASIONALLY DOWN TO LEFT LEG. AP LATERAL THREE-FOOT SCOLIOSIS FILMS TAKEN IN OUR OFFICE TODAY SHOW INSTRUMENTATION FROM T11 TO THE SACRUM. HE HAS GOOD SAGITTAL AND CORONAL BALANCE. A BROKEN ILIAC WING SCREW ON THE RIGHT IS AGAIN SEEN AS PREVIOUSLY NOTED. THERE IS A QUESTION OF WHETHER THE LEFT HAND ILIAC WING CONNECTOR HAS LOST CAPTURE AT THE DISTAL ASPECT OF THE ROD ON THE RIGHT HAND SIDE. THIS DOES APPEAR TO BE DIFFERENT WHEN COMPARED TO FILMS FROM (B)(6) 2008. PATIENT UNDERWENT X-RAY: AP LATERAL SCOLIOSIS FILMS. FINDINGS: X-RAYS SHOW THE PATIENT TO BE INSTRUMENTED FROM T11 TO THE SACRUM. HE DOES HAVE A BROKEN ILIAC WING SCREW ON THE RIGHT, HIS ROD HAS DISENGAGED FROM THE ILIAC BOLT ON THE LEFT. HIS SAGITTAL ALIGNMENT IS STILL WELL MAINTAINED. HE HAS GOOD OVERALL LUMBAR LORDOSIS. POSTERIOR LATERAL FUSION APPEARS TO BE PROGRESSING ALONG. ON (B)(6) 2008: PATIENT PRESENTED FOR FOLLOW-UP. PATIENT REPORTED LOW BACK AND RIGHT LEG PAIN. ON (B)(6) 2008: PATIENT PRESENTED FOR SIX MONTH FOLLOW-UP. PATIENT REPORTED PAIN IN NECK, UPPER AS WELL AS LOWER BACK. AP LATERAL SCOLIOSIS FILMS OBTAINED DO SHOW HIM TO HAVE SLIGHT PITCHING FORWARD. THIS IS REALLY UPPER THORACIC SPINE. THE LUMBAR SPINE IS REALLY UNCHANGED. HE DOES HAVE A BROKEN ILIAC SCREW AND DISSOCIATION OF THE ILIAC WING SCREW ON THE OPPOSITE SIDE. THE OSTEOTOMY IS INTACT. HE APPEARS TO BE HEALING. ON (B)(6) 2008: PATIENT PRESENTED FOR FOLLOW-UP VISIT. PATIENT REPORTED SOME PAIN IN LOWER BACK, UPPER BACK AND NECK. AP LATERAL SCOLIOSIS FILMS TAKEN IN THE OFFICE TODAY, (B)(6) 2008, SHOW HIM TO BE SLIGHTLY PITCHED FORWARD. THIS APPEARS TO BE ACTING FROM THE UPPER THORACIC SPINE. THERE IS NO INTERVAL CHANGE NOTED COMPARED TO PREVIOUS FILMS. AS NOTED PREVIOUSLY, THE PATIENT DOES HAVE A BROKEN ILIAC WING SCREW ON THE LEFT AND DISASSOCIATION OF THE ILIAC WING SCREW ON THE OPPOSITE SIDE. THIS IS UNCHANGED. THE OSTEOTOMY IS INTACT. ON (B)(6) 2008, PATIENT PRESENTED FOR FOLLOW-UP. PATIENT REPORTED FATIGUE AFTER WALKING AND STANDING FOR LONG PERIODS OF TIME AND PAIN IN MID, UPPER BACK AND NECK PAIN. AP LATERAL THREE-FOOT SCOLIOSIS FILMS TAKEN IN THE OFFICE TODAY SHOW THE PATIENT TO BE INSTRUMENTED FROM T11 TO THE SACRUM. HE IS STATUS POST L3 PEDICLE SUBTRACTION OSTEOTOMY. THERE DOES NOT APPEAR TO BE ANY INTERVAL CHANGE IN REGARD TO HIS ALIGNMENT OR HIS INSTRUMENTATION FROM PRIOR FILMS. AS PREVIOUSLY NOTED THERE THE PATIENT HAS A BROKEN ILIAC WING SCREW AND DISASSOCIATION OF THE LEFT ILIAC WING SCREW FROM THE ROD. CERVICAL SPINE SEEN ON THE THREE-FOOT SCOLIOSIS FILMS SHOW SIGNIFICANT SPONDYLOSIS AT MULTIPLE LEVELS WITH NO EVIDENCE OF INSTABILITY. ASSESSMENT: ONE YEAR STATUS POST T11-S1 POSTERIOR INSTRUMENTATION AND FUSION WITH PEDICLE SUBTRACTION OSTEOTOMY. NECK WITH RADICULAR ARM COMPLAINTS AS WELL AS SUBJECTIVE COMPLAINTS CONSISTENT WITH MYELOPATHY. ON (B)(6) 2008, PATIENT PRESENTED FOR FOLLOW-UP. PATIENT IS HAVING ISSUES WITH UPPER EXTREMITIES AND BALANCE. MRI OBTAINED (B)(6) 2008 DOES SHOW A MODERATE AMOUNT OF STENOSIS AT THE C4-5, C5-6 LEVEL. IT IS DIFFICULT TO TELL BECAUSE OF HIS BODY HABITUS. ON (B)(6) 2008: PATIENT PRESENTED FOR FOLLOW-UP ON CERVICAL MYELOPATHY. A CT MYELOGRAM SHOWS SEVERE STENOSIS AT THE C3-4, C4-5 AND C5-6 LEVEL AND MODERATE TO SEVERE STENOSIS AT THE C6-7 LEVEL. ON (B)(6) 2009, PATIENT PRESENTED WITH COMPLAINTS OF LOW BACK AND RIGHT LEG PAIN. AP LATERAL THREE-FOOT SCOLIOSIS FILMS SHOW NO INTERVAL CHANGE WHEN COMPARED TO HIS LAST FILMS TAKEN IN OUR OFFICE. AS PREVIOUSLY NOTED HE DOES HAVE AN ILIAC WING SCREW THAT HAS BROKEN AS WELL AS DISSOCIATION OF THE ROD WITH THE CONNECTOR AT THE LEFT HAND SIDE ILIAC WING FIXATION POINT. THERE HAS NOT BEEN MUCH INTERVAL CHANGE IN OVERALL ALIGNMENT. THERE IS SOME MILD PROXIMAL JUNCTIONAL KYPHOSIS. ASSESSMENT: LOW BACK AND RECURRENT LEG PAIN IN A PATIENT WITH A PAST HISTORY OF PEDICLE SUBTRACTION OSTEOTOMY, DECOMPRESSION, POSTERIOR INSTRUMENTATION AND FUSION FOR FLATBACK DEFORMITY. ON (B)(6) 2009, PATIENT PRESENTED FOR FOLLOW-UP ON CERVICAL LAMINOPLASTY FOR MYELOPATHY. AP LATERAL WITH A SWIMMER'S VIEW OF THE CERVICAL SPINE SHOWS THE LAMINOPLASTY TO BE INTACT. THERE IS NO EVIDENCE OF INSTABILITY. THERE IS NO EVIDENCE OF INSTRUMENTATION FAILURE. ON (B)(6) 2009, PATIENT PRESENTED FOR FOLLOW-UP ON CERVICAL LAMINOPLASTY. PATIENT REPORTED NECK PAIN AND BACK PAIN. AP LATERAL CERVICAL SPINE FILM OBTAINED (B)(6) 2009 SHOWED THE LAMINOPLASTY TO BE INTACT. THERE IS NO EVIDENCE OF LOOSENING. THERE IS NO EVIDENCE OF INSTABILITY. ON (B)(6) 2009, PATIENT PRESENTED FOR FOLLOW-UP VISIT. PATIENT REPORTED NECK PAIN WHENEVER HE STANDS OR WALKS FOR ANY AMOUNT OF TIME. PATIENT ALSO HAD NUMBNESS AND TINGLING IN RIGHT ARM AND NUMBNESS IN RIGHT FOOT. AP LATERAL CERVICAL SPINE FILM SHOWED THE LAMINOPLASTY TO BE INTACT. THERE IS NO EVIDENCE OF LOOSENING. THERE IS NO EVIDENCE OF INSTABILITY. ON (B)(6) 2010, PATIENT PRESENTED FOR FOLLOW-UP. AP, LATERAL, SCOLIOSIS FILMS OBTAINED (B)(6) 2010 SHOW THE PATIENT TO HAVE A PEDICLE SUBTRACTION OSTEOTOMY. HE IS WELL BALANCED IN THE SAGITTAL AND CORONAL PLANES. HE HAS A BROKEN ILIAC SCREW ON THE RIGHT. IT LOOKS LIKE HE HAS A DECENT POSTEROLATERAL FUSION, BUT IT IS DIFFICULT TO TELL SECONDARY TO THE INSTRUMENTATION. THERE IS LOSS OF FIXATION TO THE SACRAL SCREW AS WELL ON THE LEFT HAND SIDE. AP, LATERAL X-RAY OF THE CERVICAL SPINE SHOWED THE LAMINOPLASTY PLATES TO BE INTACT GOOD CERVICAL LORDOSIS. NO EVIDENCE OF LOOSENING OF THE PLATES. ON (B)(6) 2011, PATIENT PRESENTED FOR FOLLOW-UP FOR 3 YEAR POSTOPERATIVE APPOINTMENT FOR HIS LUMBAR FUSION SURGERY. PATIENT REPORTED OCCASIONAL BACK AND LEG PAIN. HE ALSO EXPERIENCES NUMBNESS IN HIS LEGS BUT DENIES ANY SIGNIFICANT LEG WEAKNESS. SCOLIOSIS X-RAYS WERE OBTAINED IN THE OFFICE TODAY, (B)(6) 2011, WHICH SHOWS THE INSTRUMENTATION IN GOOD POSITION FROM T11 TO THE PELVIS. NO EVIDENCE OF LOOSENING OR BREAKS IN THE INSTRUMENTATION. ON (B)(6) 2012, PATIENT PRESENTED FOR FOLLOW-UP. PATIENT WAS RECENTLY DIAGNOSED WITH INFECTION OVER HIS PREVIOUS INCISION FROM HIS SPINAL SURGERY, REDNESS AND SWELLING ALONG THE BASE OF HIS INCISION. SCOLIOSIS X-RAYS ARE OBTAINED IN THE OFFICE WHICH SHOWED INSTRUMENTATION IN GOOD POSITION FROM T11L TO THE PELVIS. HE HAS A KNOWN BROKEN RIGHT ILIAC SCREW BUT OTHERWISE THE REMAINING INSTRUMENTATION REMAINS IN GOOD POSITION. ON (B)(6) 2012, PATIENT PRESENTED FOR OFFICE VISIT WITH INCREASING CONCERNS OF LOW BACK PAIN. PATIENT REPORTED THAT THE AREA ALONG THE INCISION CONTINUES TO WORSEN AND NOW THE PAIN IS WORSENING AS WELL AS INCREASING REDNESS AND SWELLING AROUND THE INCISION. AN MRI SCAN REVIEWED FROM (B)(6) 2012 SHOWS A SMALL SUBCUTANEOUS MIDLINE FLUID COLLECTION AT THE S1 LEVEL WITHOUT AREA OF ENHANCEMENT. ON (B)(6) 2012, PATIENT PRESENTED FOR FOLLOW-UP VISIT. PATIENT REPORTED THAT WOUND WAS PAINFUL. ON (B)(6) 2012, PATIENT PRESENTED FOR FOLLOW-UP VISIT. X-RAYS OBTAINED SHOW HINT TO BE INSTRUMENTED FROM T11 DOWN TO THE PELVIS. HE HAS THE BROKEN SCREW WHICH IS UNCHANGED. IT LOOKS LIKE HE HAS A SOLID POSTEROLATERAL FUSION MASS. ON (B)(6) 2012, PATIENT PRESENTED FOR FOLLOW-UP VISIT. PATIENT WAS CLEARED FOR REMOVAL OF INSTRUMENTATION AND POSSIBLE RE-INSTRUMENTATION IF HE WAS NOT FUSED. X-RAYS OBTAINED SHOW HIM TO BE INSTRUMENTED FROM T11 DOWN TO THE PELVIS. HE DOES HAVE A PSO. HE HAS A BROKEN SCREW ON THE ILIAC. THERE IS LOSS OF HIS END CAP AT S1.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 124488 | CD HORIZON SPINAL SYSTEM | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | KWP | MEDTRONIC SOFAMOR DANEK | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00052 YR | Required Intervention |