MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Catalog Number 7510400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ossification (1428); Edema (1820); Headache (1880); Nerve Damage (1979); Swelling (2091); Weakness (2145); Stenosis (2263); Depression (2361); Numbness (2415); Sleep Dysfunction (2517); Cancer (3262)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Note: 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.Products from multiple manufacturers were implanted during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.

Event Description

It was reported that on: (b)(6) 2003: patient presented with chronic intractable low back pain status post lumbar de-compressive procedures with persistent back pain.The patient has failed all conservative measures.Patient underwent multiple courses of physical therapies without any relief.Assessment: degenerative disc disease l3-4, l4-5, l5-s1.L5 foraminal stenosis.Preoperative diagnoses: degenerative disc disease, l3-l4, l4-l5, l5-s1, l5 radiculopathy, l5 foraminal stenosis.Patient underwent following procedures: anterior interbody fusion, l3-l4, l4-l5, l5-s1 using lt cages with bnp, followed by instrumented l3-s1 fusion with bilateral iliac crest graft.Instrumentation system used.Patient also underwent exposure of anterior interbody fusion of l3-s1 for anterior interbody fusion.Per op notes, anterior retroperitoneal exposure was carried out by surgeon.A midline 18 x 22 mm cage was placed.At l4-5 segment, the 14x 22 mm cages were placed.Trajectory as previous was determined by ap lateral fluoroscopy.The disc was removed and a 14 mm double barrel retractor was placed after sequential distraction at this level, after which 14 x 20 cages were placed at bnp.Crest was exposed using subperiosteal technique.The screws were placed under fluoroscopic guidance.At no time was there violation of any of the cortices of the pedicle.Screws were placed at l3 and l4 bilaterally and s1 bilaterally.The 7.5 screws were placed in s1 15 mm in length and 45 and 50 mm screws were placed in the l3-l4 pedicles.Generous bone graft was placed.This was put in place with osteofil.Rods were contoured for lordosis.Connectors were replaced on the rods.Connectors were placed over the pedicle screws and tightened.Patient underwent intra-operative lumbar spine x-ray.Impression: there are interspacing cages at the l4-l5 and l5-s1 levels.No complications reported.On (b)(6) 2003: patient was discharged to home.On (b)(6) 2003: patient presented for follow up post-op.Patient¿s axial spine pain was improved since surgery.X-ray showed satisfactory healing.He has had some subsidence across the 3-4 segments.On (b)(6) 2003: per the billing records the patient underwent unknown radiological test.On (b)(6) 2004: patient presented for follow up with back pain.On (b)(6) 2004: patient presented with constant extreme pain and described the pain as sharp, throbbing, aching, burning type pain with numbness and weakness in the back and tingling in the legs.His pain drawing showed a numbness the anterior thighs bilaterally, numbness and burning in the posterior thighs bilaterally, and pain in the upper lumbar area.X-rays taken today showed three-level lt cages at 3-4, 4-5, and 5-1 with apparent good healing, plus lateral grafting at 3-4 and 4-5 and to a lesser degree at 5-1.He has posterior modified instrumentation which is in good position with no evidence of loosening.Impression: previous herniated disc, status post three-level front and back surgery; dysesthetic pain in his lateral femoral cutaneous nerve distribution.On (b)(6) 2004: patient presented with chronic back pain.Patient stated that he would have pain off and on from that time up until (b)(6) 2002, at which time he stepped off a curb and had more persistent low back pain.Despite physical therapy he persisted with his back pain.Subsequent to this lumbar fusion he has had worse back pain with bilateral hip pain as well.He had felt some kind of weakness and tingling in his legs.Patient was positive for depression and anxiety as well as sleep difficulty.Neck was supple.On (b)(6) 2004: patient presented with severe back pain.On (b)(6) 2004: patient underwent spinal fusion anterior/posterior approach at 3 levels, l3-4, l4-5, and l5-s1.On (b)(6) 2004: patient presented with difficulty in urinating.Patient felt the need but could not urinate.Patient also complained of erectile dysfunction.Bladder ultrasound showed minimal post void residual.On (b)(6) 2004: patient presented with back pain and bilateral leg pain.Pain was 10/10 in severity.Pain was described as constant, deep, stiff, and aching.Patient had dysfunction of his sexual functions including ejaculation and erection.Patient had numbness and pain down both lower extremities.Examination of his x-rays showed healing of the fusion at both interbody and posterior lateral with pedicle screws and interbody lt cages.There is no mal-position of the hardware.Assessment/plan: failed back syndrome.On (b)(6) 2004: the patient presented with low back pain.He has also had some difficulties with urination and sexual dysfunction and significant sleep disturbance and depression.Pain was still unrelenting.Patient had problems with numbness also in the fingers and some swelling in the ankles.Physical examination revealed trace edema in his lower extremities.Patrick's, piriformis provocation are also positive.The remainder of the exam showed thoracic as well as lumbar spine pain throughout the spine.He has otherwise numbness in lower extremities below the level of the knee with decreased vibratory sensation.Impression: failed back syndrome.On (b)(6) 2004: per the medical records the patient underwent therapeutic sessions.On (b)(6) 2004: patient presented with elevated back pain, hypertension.On (b)(6) 2005: patient presented for follow up.The patient is not responding to physical therapy.Patient had overall been doing fair and there were no significant changes in his condition.On (b)(6) 2005: the patient presented with constipation, urinary tract problems, and micturition.Patient also stated he was impotent.Patient was maximally limited in all planes of the lumbar spine.Patient ambulated with a straight cane and stood with a forward-bent posture.Deep tendon reflexes in bilateral lower extremities were assent.Patient had strength deficits in bilateral lower extremities, however that was give-away weakness and cog wheeling with all manual muscle testing.Patient's lower extremity flexibility was poor, and the patient had symptoms of an si joint rotation.Diagnosis: low back pain, failed back syndrome.Patient underwent physical therapy exercises.On (b)(6) 2005, the patient presented with admitting diagnosis of failed back syndrome.The patient underwent ct of lumbar with contrast due to failed back syndrome.Impression: no convincing evidence of arachnoiditis.Bilateral foraminal stenosis at l5-s1.L5 and s1 grade 1 spondylolisthesis.On (b)(6) 2005: the patient presented with significant pain.Patient had overall been doing fair and there were no significant changes in his condition.On (b)(6) 2005: patient underwent chest x-ray due to cardiomegaly.Impression: mild cardiomegaly.Mild pulmonary hyperinflation.No acute change.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: INFUSE BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5797436
• MDR Text Key: 49621328
• Report Number: 1030489-2016-02072
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 07/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7510400
• Device Lot Number: M01110049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/08/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 120