CD HORIZON SPINAL SYSTEM
Report
- Report Number
- 1030489-2013-00523
- Event Type
- Injury
- Date Received
- February 15, 2013
- Report Date
- August 15, 2013
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA
- Product Code
- KWP
- PMA / PMN Number
- UNKNOWN
- 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.
ON (B)(6) 2007 THE PATIENT PRESENTED FOR PRE-OP PHYSICAL. PER THE PHYSICIAN'S NOTES, THE PATIENT "HAS A DIFFICULT TIME WITH HER PAIN. SHE HAS BEEN COMPLIANT WITH THE PAIN MEDS AND NARCOTICS. SHE HAS BEEN GETTING IN TO THE MAPS NOW TO TRY OTHER NON PHARMACOLOGIC MODALITIES." ON (B)(6) 2012 THE PATIENT PRESENTED FOR AN OFFICE VISIT. PER THE PHYSICIAN'S NOTES, THE PATIENT REPORTS "CONSTANT DIFFUSE PAIN. BILATERAL HISP AND HER ENTIRE LOWER EXTREMITIES HAVE BEEN MOST PAINFUL... HER PAIN INCREASES WITH ACTIVITY AS WELL AS CHANGES IN BAROMETRIC PRESSURE AND AWAKENS HER FROM SLEEP AT NIGHT... SHE ALSO HAS POST-REST GELLING. SHE HAS CHRONIC LOW BACK PAIN, STATUS POST LUMBAR SPINE SURGERY X5, WHICH HAS RESULTED IN 30% RESOLUTION OF HER DISCOMFORT. SHE HAS ALSO BEEN TOLD THAT A MRI OF HER PELVIS REVEALS "PINCHED NERVES AND ARTERIES" FOR WHICH {SURGEON], ORTHOPEDIC SURGERY HAS RECOMMENDED SURGICAL INTERVENTION."
ON (B)(6) 2001 DATE OF INJURY (B)(6) 2006 PATIENT HAD BACK SURGERY. ON (B)(6) 2007 HARDWARE REMOVAL (B)(6) 2007 SPINAL FUSION (B)(6) 2008 PATIENT PRESENTED COMPLAINING OF MIGRAINES, PAIN, TINGLING, NUMBNESS IN THE FRONT OF THE LEFT THIGH AND STOMACH. ON (B)(6) 2008 SURGERY CONSISTING OF HARDWARE REMOVAL AND DECOMPRESSION. ON (B)(6) 2008 PATIENT PRESENTED REPORTING RECURRENCE OF CRAMPING IN THE LEGS, BILATERALLY. ON (B)(6) 2008 PATIENT PRESENTED COMPLAINING OF CONSTANT PAIN SHOOTING INTO BOTH LEGS. ON (B)(6) 2009 PATIENT PRESENTED COMPLAINING OF LEFT LEG NUMBNESS AND A STABBING TIGHTNESS IN HER BACK. SHE REPORTS THAT SHE IS PROGRESSIVELY GETTING WORSE SINCE HER SURGERY. ON (B)(6) 2009 THE PATIENT PRESENTED COMPLAINING OF PAIN. SHE ALSO HAD AN EPISODE OF INCONTINENCE. ON (B)(6) 2009 PATIENT REPORTED PAIN. ON (B)(6) 2009 PATIENT PRESENTED COMPLAINING THAT HER PAIN AND SYMPTOMS HAD GOTTEN WORSE. PATIENT COMPLAINED OF LEG NUMBNESS OFF AND ON WITH LAYING DOWN. (B)(6) 2009 SURGERY (B)(6) 2009 THE PATIENT PRESENTED FOR FOLLOW UP. THE PATIENT REPORTED THAT SHE FELT BETTER AFTER HER SURGERY, BUT THAT A COUPLE OF WEEKS AGO HER PAIN INCREASED. THE PATIENT FEELS THAT IT IS THE HARDWARE CAUSING THE PAIN. ON (B)(6) 2010 THE PATIENT PRESENTED FOR FOLLOW UP COMPLAINING OF WORSENING PAIN. ON (B)(6) 2010 PATIENT PRESENTED FOR FOLLOW UP. SURGEON NOTED 'DEPRESSED, FLAT, 10/10 PAIN.' THE PATIENT REPORTED THAT THE PAIN MOVED HIGHER UP IN HER BACK. ON (B)(6) 2010 PER PHYSICIAN'S NOTES, 'NO CHANGE SINCE LAST VISIT.'
(B)(6) 2006 OPERATIVE REPORT FOR SPINAL FUSION- L5-S1 MAST TLIF, POSTEROLATERAL FUSION L5-S1, POSTERIOR LUMBAR INTERBODY FUSION L5-S1, APPLICATION OF INTERBODY DEVICE L5-S1, LARGE INFUSE. (B)(6) 2007 OPERATIVE REPORT FOR HARDWARE REMOVAL: PATIENT DIAGNOSED WITH BILATERAL PAINFUL HARDWARE, POSSIBLE NONUNION. REMOVAL OF HARDWARE. (B)(6) 2007: OPERATIVE REPORT FOR REVISION OF PRIOR POSTERIOR SPINAL FUSION, AND THEY DID ANOTHER FUSION WITH BMP. PATIENT DIAGNOSED WITH NONUNION AT L5-S1. PROCEDURE: ANTERIOR ALLOGRAFTING WITH BMP, APPLICATION OF CRUSHED CANCELLOUS BONE ALLOGRAFT, REMOVAL OF INTERBODY SPACER, POSTERIOR FUSION WITH BMP. (B)(6) 2008: OPERATIVE REPORT FOR DISC DECOMPRESSION AND HARDWARE REMOVAL. PROCEDURE: DECOMPRESSIVE HEMILAMINOTOMY L4-5, REMOVAL OF SCREWS. (B)(6) 2009: OPERATIVE REPORT FOR REVISION SURGERY WITH SPINAL FUSION- DX'D WITH INTRACTABLE PAIN, KYPTHOTIC DEFORMITY L4-5. REVISION SURGERY: POSTERIOR LUMBAR FUSION USING LEGACY PEDICLE SCREWS AND BMP-2. REPORTEDLY, THE PATIENT IS EXPERIENCING CHRONIC/SEVERE/STABBING/ACHING/THROBBING PAIN, LEG NUMBNESS/TINGLING, EXCRUCIATING, STINGING PAIN ABOVE TAILBONE, LEG WEAKNESS, FIBROMYALGIA, LEGS CRAMP, SPASMS IN LOWER EXTREMITIES, BUTTOCK PAIN, FEELS LIKE ELECTRIC SHOCKS ALL OVER BODY, PAIN IMPAIRS FUNCTIONING,PAIN RELATING TO HARDWARE AFTER IMPLANTED (B)(6) 2006, LOSS OF BLADDER CONTROL ((B)(6) 2008, (B)(6) 2009), ARMS/HANDS NUMB, HIP PAIN, PARESTHESIA IN BOTH LEGS (DIAGNOSED IN ER RECORD (B)(6) 2009).
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH DEGENERATIVE DISC DISEASE WITH CHRONIC BACK PAIN UNRESPONSIVE TO CONSERVATIVE CARE. THE PATIENT UNDERWENT A MAST TLIF L5-S1 USING AN INTERBODY DEVICE, RHBMP-2/ACS, AND CANNULATED POSTERIOR INSTRUMENTATION. INTRAOPERATIVE RADIOLOGY REPORT INDICATED "PEDICLE SCREWS AND POSTERIOR FUSION RODS AT L5-S1 WITH ANATOMIC ALIGNMENT." THERE WERE NO NOTED COMPLICATIONS. THE PATIENT WAS DISCHARGED ON POD 1. 147 DAYS POST-OP, THE PATIENT PRESENTED WITH BILATERAL PAINFUL HARDWARE AND NON-UNION. PER THE PHYSICIAN'S NOTES, THE PATIENT "UNDERWENT AN L5-S1 MAST TLIF APPROXIMATELY 5 MONTHS AGO. INITIALLY SHE HAD EXCELLENT RELIEF OF HER PREOPERATIVE BACK PAIN BUT DID HAVE SIGNIFICANT TENDERNESS TO PALPATION OVER HER HARDWARE BILATERALLY. "HER SYMPTOMS CONTINUED TO PROGRESS AND SHE STARTED DEVELOPING HER PREOPERATIVE BACK PAIN AND SEVERE TENDERNESS TO PALPATION OVER THE HARDWARE AND WAS FELT OF HAVE BOTH PAINFUL HARDWARE AND THE POSSIBILITY OF A DELAYED UNION." THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE THE LEFT-SIDED HARDWARE. THE RIGHT-SIDED HARDWARE WAS LEFT IN PLACE. THERE WERE NO NOTED COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 66799 | CD HORIZON SPINAL SYSTEM | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | KWP | MEDTRONIC SOFAMOR DANEK USA | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |