CD HORIZON SPINAL SYSTEM
Report
- Report Number
- 1030489-2016-01516
- Event Type
- Injury
- Date Received
- May 25, 2016
- Report Date
- February 22, 2017
- Manufacturer
- MEDTRONIC SOFAMOR DANEK
- Product Code
- NKB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- ATTORNEY
Narratives
MULTIPLE PRODUCTS WERE USED IN THE SURGERY WHICH ARE AS FOLLOWS: PRODUCT ID: 7220850 QTY 4 (510K# K061915) PRODUCT ID: 7893040 QTY 2 (510K# K052609) ALTHOUGH IT IS UNKNOWN WHICH OF THESE PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. (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.
CORRECTED INFO: MULTIPLE PRODUCTS WERE USED IN THE SURGERY WHICH ARE AS FOLLOWS: PRODUCT ID: 7220850; QTY 4 (510K# K061915); UPN# (B)(4). PRODUCT ID: 7893040; QTY 2 (510K# K052609); UPN# (B)(4). ALTHOUGH IT IS UNKNOWN WHICH OF THESE PRODUCTS CAUSED OR 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 ON: (B)(6) 2008: PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSES: L5-S1 BILATERAL SPONDYLOLISTHESIS. L5-S1 SPONDYLOSIS. LEFT L5 RADICULOPATHY. FOR WHICH, PATIENT UNDERWENT FOLLOWING PROCEDURES: BILATERAL POSTERIOR SEGMENTAL SPINAL INSTRUMENTATION, L5-S1. TRANSFORAMINAL LUMBAR INTERBODY FUSION, L5-S1, WITH PLACEMENT OF INTERBODY SPACER. AUGMENTATION OF THE ANTERIOR SPINAL FUSION, L5-S1, WITH BONE MORPHOGENIC PROTEIN AND LOCAL BONE GRAFT. RIGHT POSTEROLATERAL/POSTERIOR SPINAL FUSION WITH COMPRESSIVE RESISTANT MATRIX, BONE MORPHOGENIC PROTEIN AND LOCAL BONE GRAFT. UTILIZATION OF THE MINIMAL-ACCESS SPINAL TECHNOLOGY (TUBULAR RETRACTORS). NEURAL MONITORING WITH SOMATOSENSORY EVOKED POTENTIALS AND EMG STIMULATION. PER OP NOTES, A 12X30 MM PEEK CRESCENT INTERBODY SPACER WAS PLACED WITH 2 MG OF BONE MORPHOGENIC PROTEIN. AN ADDITIONAL 4 MG OF BONE MORPHOGENIC PROTEIN ON AN ABSORBABLE COLLAGEN SPONGE WITH LOCAL BONE GRAFT HAD BEEN PACKED ANTERIORLY TO THIS. AN ADDITIONAL 6 MG OF BONE MORPHOGENIC PROTEIN ON A COMPRESSIVE RESISTANT MATRIX (5 ML) WITH LOCAL BONE GRAFT IN THE POSTEROLATERAL GUTTER. PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS. (B)(6) 2008: PATIENT GOT DISCHARGED FROM THE HOSPITAL. (B)(6) 2009: PATIENT UNDERWENT CT OF THE LUMBAR SPINE, WITHOUT CONTRAST. IMPRESSION: SEVERAL OF THE IMAGES SUGGEST AN ASYMMETRIC APPEARANCE OF POSSIBLE OSSEOUS FRAGMENTATION IN THE REGION OF THE LEFT L5-S1 INTERVERTEBRAL FORAMEN WHICH IS ALSO IN CLOSE APPROXIMATION TO THE EXISTING LEFT L5 NERVE ROOT. FINDINGS COULD BE POST-OPERATIVE IN NATURE BUT ARE SOMEWHAT CONCERNING GIVEN LEFT SIDED LEG PAIN. VERY MILD DIFFUSE DISC BULGING AT L4-L5 WITHOUT CENTRAL CANAL OR NEUROFORAMINAL STENOSIS. THE REMAINDER OF THE EXAMINATION IS WITHIN NORMAL LIMITS. (B)(6) 2008: A TELEPHONE NOTE ON THIS DATE INDICATED NERVE PAIN IN PATIENT'S LEFT LEG WITH WEAKNESS FOR WHICH NEURONTIN (GABAPENTIN) WAS PRESCRIBED TO HIM. (B)(6) 2008: THROUGH A PHONE MESSAGE, PATIENT DESCRIBED HAVING SHORTNESS OF BREATH. HE WAS RECOMMENDED TO GO TO THE LOCAL EMERGENCY HOSPITAL. (B)(6) 2008: A TELEPHONE NOTE ON THIS DATE INDICATED CONTINUED NERVE PAIN AND LEFT LEG PAIN IN PATIENT ALONG WITH SEVERE HEADACHE WITH NEURONTIN. (B)(6) 2008, (B)(6) 2009, (B)(6) 2010, PATIENT UNDERWENT TRANSFORAMINAL EPIDURAL STEROID INJECTION UNDER FLUOROSCOPIC GUIDANCE. NO COMPLICATIONS WERE REPORTED. (B)(6) 2009, PATIENT PRESENTED FOR HIS FIRST POST-OPERATIVE VISIT, AND UNDERWENT X-RAY OF LUMBAR SPINE, 2 OR 3 VIEWS, WHICH REVEALED THE PEDICLE SCREWS PLACED AT L5 AND S1 WITH A RADIOLUCENT ROD CONNECTING THEM. ONE OF THE SCREWS ON THE LATERAL IMAGE LOOKS A BIT INFERIOR. THE ALIGNMENT OF THE SCREWS ON THE AP LOOKED FINE. NO SIGNIFICANT BONE IS SEEN IN THE POSTERO-LATERAL AREA. IMPRESSION: UNCHANGED L5-S1 ANTERIOR AND POSTERIOR INSTRUMENTED FUSION. (B)(6) 2009: PATIENT PRESENTED WITH COMPLAINT OF LEFT BUTTOCK AND POSTERIOR THIGH PAIN; LEFT LEG WEAKNESS AND TIGHTNESS; AND LOW BACK PAIN. (B)(6) 2009: PATIENT PRESENTED WITH THE FOLLOWING CHIEF COMPLAINTS: LEFT-SIDED LOWER BACK PAIN, LEFT BUTTOCK PAIN TRAVELLING TO ANTERIOR DISTAL CALF TO LEFT LARGER TOE, RIGHT POSTERIOR THIGH AND POSTERIOR CALF PAIN RADIATING TO PLANTAR ASPECT OF RIGHT FOOT. EXAMINATION OF PATIENT'S LOWER BACK REVEALED ONLY MINIMAL TENDERNESS ON PALPATION. NO SPASM WAS OBSERVED. (B)(6) 2009, PATIENT UNDERWENT X-RAY OF LUMBAR SPINE, 2 OR 3 VIEWS. IMPRESSION: UNCHANGED L5-S1 ANTERIOR AND POSTERIOR INSTRUMENTED FUSION. (B)(6) 2009: PATIENT PRESENTED WITH COMPLAINT OF BURNING SENSATION IN HIS FEET BILATERALLY AND A LOT OF ISCHIAL PAIN WHEN HE SITS. IMPRESSION: L5, S1 MAST TLIF WITH PERSISTENT RADICULOPATHY LEFT GREATER THAN RIGHT- SLOWLY IMPROVING. (B)(6) 2009: PATIENT PRESENTED FOR AN OFFICE VISIT AFTER DEVELOPMENT OF LEFT S1 DISTRIBUTION PAIN PATTERN. DIAGNOSIS: FAILED SURGERY, LUMBAR SPINE. PSEUDOARTHROSIS, LUMBAR SPINE. PATIENT UNDERWENT CT OF LUMBAR SPINE WITHOUT CONTRAST AND X-RAY. IMPRESSION: POSTSURGICAL CHANGES NOTED AT L5-S1 WHERE THERE ARE BILATERAL TRANSPEDICULAR SCREWS AND INTERVERTEBRAL DISC PROSTHESIS. NO EVIDENCE OF HARDWARE FAILURE. ALIGNMENT IS MAINTAINED. BILATERAL L5 PARS DEFECTS WERE NOTED. MILD RIGHT AND MODERATE/ SEVERE LEFT NEURAL FORAMINAL NARROWING AT L5-S1 ON THE BASIS OF DISC BULGE/ FACET CHANGES. POSTOP CALCIFIED SCAR TISSUE MAY ALSO BE CONTRIBUTING TO IMPINGEMENT OF THE EXITING LEFT L5 NERVE ROOT. NO SIGNIFICANT CENTRAL CANAL OR NEURAL FORAMINAL NARROWING AT THE UPPER LIMB LEVELS. PATIENT ALSO UNDERWENT ELECTRO DIAGNOSTIC STUDY. THERE WAS NO EVIDENCE OF ACUTE OR CHRONIC DENERVATION TO SUPPORT A DIAGNOSIS OF RADICULOPATHY. (B)(6) 2009: PATIENT PRESENTED FOR AN OFFICE VISIT REGARDING HIS LEFT HIP AND LEG PAIN.(B)(6) 2009: PATIENT VISITED OFFICE FOR FOLLOW UP OF HIS L5 RADICULOPATHY THAT CAME ON WITH A PERCUTANEOUS MINIMALLY INVASIVE SPINAL FUSION AT THE L5-S1 LEVEL. (B)(6) 2009, PATIENT PRESENTED WITH CHIEF COMPLAINTS OF BACK PAIN AND LEG PAIN; AND UNDERWENT X-RAY OF LUMBAR SPINE COMPLETE WITH BENDING. IMPRESSION: UNCHANGED INSTRUMENTED POSTERIOR L5-S1 FUSION AND DISCECTOMY AND ANTERIOR FUSION, L5-S1. THERE IS NO MOTION OF THE FUSED SEGMENT WITH FLEXION AND EXTENSION. (B)(6) 2009: PATIENT UNDERWENT AN MRI OF THE LUMBOSACRAL SPINE. THIS DEMONSTRATED EVIDENCE OF POST-SURGICAL CHANGES AT L5-S1. THERE IS EVIDENCE OF ENHANCING GRANULATION TISSUE AT THE L5-S1 LEVEL CENTERED ABOUT THE LEFT NEUROFORAMEN ABUTTING THE LEFT EXISTING NERVE. (B)(6) 2009, THE PATIENT PRESENTED FOR PRE-OP EVALUATION. THE PATIENT DESCRIBED HIS PAIN AT LEFT LEG AND BACK AS ACHING AND BURNING. (B)(6) 2009, THE PATIENT WAS ADMITTED DUE TO LOW BACK PAIN AND PRIMARY DIAGNOSIS: MECHANICAL COMPLICATION OF OTHER INTERNAL ORTHOPAEDIC DEVICE , IMPLANT AND GRAFT. L4/5 PSEUDOARTHROSIS ; REVISION L4/5 POSTERIOR SPINAL FUSION. SECONDARY DIAGNOSIS WERE: INJURY OR POISIONING OCCURRING IN /AT UNSPECIFIED SITE . THE PRE-OP DIAGNOSIS WERE: LEFT L5-S1 FORAMINAL STENOSIS . LEFT L5 RADICULOPATHY. PSEUDOARTHROSIS AT L5-S1 STATUS POST POSTERIOR SPINAL FUSION WITH INSTRUMENTATION AND TLIF AT L5-S1 PERFORMED AT L5-S1 IN 2008. THE PATIENT UNDERWENT FOLLOWING PROCEDURE: REMOVAL OF POSTERIOR NON SEGMENTAL SPINAL INSTRUMENTATION FROM L5-S1 . EXPLORATION OF POSTERIOR SPINAL FUSION WITH CONFIRMATION OF PSEUDOARTHROSIS AT L5-S1. COMPLEX REVISION POSTERIOR SPINAL FUSION AT L5-S1. COMPLEX REVISION POSTERIOR NON SEGMENTAL SPINAL INSTRUMENTATION FROM L5-S1 USING MEDTRONIC LEGACY PEEK ROD SYSTEM. USE OF MORCELIZED LOCAL BONE GRAFT. PER OP-NOTES, ¿.. THE SURGEON REMOVED THE SET SCREWS, BILATERALLY. THE PEEK RODS WERE REMOVED BILATERALLY . SCREWS WERE DOING GOOD.. THE REMAINING POSTERIOR ELEMENTS WERE THOROUGHLY DECORTICATED , .. THE SURGEON INSERTED PEEK RODS INTO THE SCREWS BILATERALLY AND SECURED THEM IN PLACE USING SET SCREWS ¿ THEN 10ML OF MORCELIZED LOCAL BONE GRAFT WAS PLACED OVER THE DECORTICATED POSTERIOR ELEMENTS¿¿
IT WAS REPORTED THAT ON: (B)(6) 2008: ON A TELEPHONIC CONVERSATION, PATIENT STATED THAT SHE HAD LOT OF LEFT LEG PAIN. LEFT FOOT AND ANKLE BURNS ALL THE TIME. ON (B)(6) 2009: THE PATIENT UNDERWENT MRI OF LUMBAR SPINE WITH AND WITHOUT CONTRAST DUE TO RIGHT LEG PAIN AND PERSISTENT LUMBAR PAIN. IMPRESSION: POST-OPERATIVE CHANGES AT THE L5-S1 LEVEL WITH GRANULATION TISSUE NOTED, PREDOMINATELY ON THE LEFT, AND INVOLVING THE LEFT NEUROFORAMEN AND LIKELY CONTACTING THE LEFT EXITING NERVE ROOT. NO EVIDENCE OF DESCENDING NERVE ROOT IMPINGEMENT. NO EVIDENCE OF SIGNIFICANT NEUROFORAMINAL ENCROACHMENT ON THE RIGHT AT ANY LEVEL. NO ABNORMAL ENHANCEMENT IDENTIFIED. ON (B)(6) 2009: THE PATIENT UNDERWENT CT OF THE LUMBAR SPINE WITHOUT CONTRAST. IMPRESSION: FINDINGS OF LUMBAR FUSION AT L5-S1, SEVERAL OF THE IMAGES SUGGEST AS ASYMMETRIC APPEARANCE OF POSSIBLE OSSEOUS FRAGMENTATION IN THE REGION OF THE LEFT L5-S1 INTERVERTEBRAL FORAMEN WHICH IS ALSO IN CLOSE APPROXIMATION TO THE EXITING LEFT L5 NERVE ROOT. VERY MILD DIFFUSE DISC BULGING AT L4-L5 WITHOUT CENTRAL CANAL OR NEUROFORAMINAL STENOSIS.
IT WAS REPORTED THAT ON: (B)(6) 2009: PATIENT PRESENTED FOR OFFICE VISIT AND COMPLAINS OF MILD LOW BACK PAIN AND LEFT LOWER EXTREMITY RADICULAR SYMPTOMS SAME AS PRIOR THE SURGERY. IMPRESSION: SATISFACTORY FOLLOW UP STATUS POST REVISION POSTERIOR SPINAL FUSION WITH INSTRUMENTATION AND DECOMPRESSION ON THE LEFT AT L5-S1. ON (B)(6) 2010: PATIENT UNDERWENT ULTRASOUND OF BOTH BREASTS. SUMMARY: SOLID LESIONS IN THE RETROAREOLAR SPACE ASPECTS OF BOTH BREASTS AND WITH A HISTORY OF ENLARGING PALPABLE LUMP IN THE LEFT BREAST, SURGICAL BIOPSY OF THE LEFT RETROAREOLAR MASS IS SUGGESTED. ON (B)(6) 2010: PATIENT PRESENTED FOR OFFICE VISIT FOR FOLLOW-UP ON PAIN IN LOWER LUMBAR AREA. ON (B)(6) 2010, PATIENT PRESENTED FOR OFFICE VISIT AND REPORTED SEVERE LOW BACK PAIN, STIFFNESS, MUSCLE SPASMS, RESTRICTED RANGE OF MOTION IN LOWER BACK, DIFFICULTY IN STANDING, SITTING AND WALKING, PAIN IN HIPS AND LEFT LEG, PINS AND NEEDLES IN BOTH LEGS. PATIENT ALSO REPORTED SEVERE NUMBNESS IN LEFT LEG, DIFFICULTY IN SLEEPING, SEVERE DEPRESSION AND MODERATE TO SEVERE ANXIETY. ON (B)(6) 2010: PLAIN RADIOGRAPHS OF THE LUMBOSACRAL SPINE DEMONSTRATE EVIDENCE OF A POSTERIOR FUSION WITH INSTRUMENTATION AND TLIF AT L5-S1 WITH A DECOMPRESSION ON THE LEFT SIDE. ALL IMPLANTS APPEAR TO BE IN GOOD POSITION AND THERE IS NO EVIDENCE OF IMPLANT LOOSENING OR IMPLANT FAILURE. ON (B)(6) 2010: PATIENT CALLED REQUESTING A ¿POSITIONAL MRI¿ SINCE ALL HIS PAIN IS WHEN SITTING STANDING OR BENDING OVER. ON (B)(6) 2010: PATIENT UNDERWENT X-RAY OF RIGHT SHOULDER DUE TO HISTORY OF TRAUMA AND PAIN. IMPRESSION: NO RADIOGRAPHIC EVIDENCE OF BONE OR JOINT DISEASE OF THE RIGHT SHOULDER. PATIENT ALSO UNDERWENT X-RAY OF CLAVICLE DUE TO HISTORY OF TRAUMA AND PAIN. IMPRESSION: NO RADIOGRAPHIC EVIDENCE OF FRACTURE, DISLOCATION OR OTHER ABNORMALITY OF THE RIGHT CLAVICLE. ON (B)(6) 2010: PATIENT UNDERWENT RIGHT SHOULDER MRI DUE TO HISTORY OF TRAUMA, PAIN. IMPRESSION: SIGNAL ABNORMALITIES OF THE DISTAL SUPRASPINOUS AND SUBSCAPULARIS TENDONS NEAR THE INSERTION SITES SUGGEST AREAS OF FOCAL STRAIN AND OR TENDINOPATHY. NO DISCRETE TEAR OF THE ROTATOR CUFF IS SEEN AT THIS TIME. THERE IS MINIMAL AC JOINT HYPERTROPHY. NO DISCRETE TEAR OF THE LABRUM IS SEEN AT THIS TIME. ON (B)(6) 2010, PATIENT PRESENTED FOR OFFICE VISIT. ON (B)(6) 2014, PATIENT PRESENTED FOR OFFICE VISIT AND REPORTED INTERMITTENT SHARP, BURNING, DULL AND ACHING MODERATE TO SEVERE PAIN ACROSS LUMBAR REGION WITH PAIN RADIATING TO GLUTE, PARTICULARLY SIT DOWN AND INTO THE POSTERIOR THIGH AND RIGHT HEEL AND PLANTAR SURFACE OF FOOT. LEGS FELT WEAKER WITH INCREASE IN PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 333114 | CD HORIZON SPINAL SYSTEM | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | NKB | MEDTRONIC SOFAMOR DANEK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |