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

Catalog Number 7510200

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

Patient Problems Chest Pain (1776); Headache (1880); Neuropathy (1983); Urinary Tract Infection (2120); Tingling (2171); Stenosis (2263); Numbness (2415); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

(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.

Event Description

It was reported that on (b)(6) 2005, patient underwent following procedure: decompressive lumbar laminectomy at l4-5 and l5-s1 with medial facetectomies and foraminotomies bilaterally, posterior lumbar interbody fusion at l4-5 and l5-s1 with peek cages and bone morphogenic protein, insertion of biomechanical devices at l4-5 and l5-s1, posterolateral fusion l4-s1 with morselized allograft, pedicle screw instrumentation at l4, l5 and s1; for pre-op diagnosis of: degenerative disc disease l4-5 and l5-s1, herniated nucleus polposus at l5-s1, lumbar spinal stenosis at l4-5 and l5-s1 and post-op diagnosis of degenerative disc disease l4-5 and l5-s1, herniated nucleus polposus at l5-s1, lumbar spinal stenosis at l4-5 and l5-s1, spinal instability at l4-5.Per-op notes: "the fascia was divided in midline and paraspinal musculature was elevated in the subperiosteal fashion from the spinous processing lamina of l4, l5 and s1.The exposure took and extra amount of time due to patient's extremely large size.A synovial cyst was encountered on the left at l5-s1.A very aggressive decompressive laminectomy was performed with medial facetectomies and foraminotomies bilaterally.A 12 x 22mm cage was packed with sponge containing bmp.Ap and lateral c-arm fluoroscopy confirmed its positioning.This was repeated on the contralateral side and confirmed with fluoroscopy.This process was repeated at l5-s1 interspace.An 8 x 22mm peek cage was packed with bmp and inserted into l5-s1 interspace.Procedure was repeated on contralateral side and confirmed by fluoroscopy." on (b)(6) 2010, patient underwent procedure for implantation of permanent dorsal column stimulator; for pre-op diagnosis of: failed back syndrome with radiculopathy and spinal stenosis.No complications were reported.On (b)(6) 2013, patient presented for office visit.Diagnosis: chest pain, chronic pain, gerd, bipolar disorder, hypertension.On (b)(6) 2013, patient presented for office visit for medication refill.On (b)(6) 2013, patient presented for office visit for complaint of numbness and tingling in both thumbs.Patient underwent x-ray of left wrist, emg and nerve conduction study.On (b)(6) 2013, patient underwent emg.Conclusion: this is an abnormal electrophysiology study consistent with severe left carpal tunnel syndrome.Moderate right carpal tunnel syndrome.Mild bilateral ulnar entrapment neuropathy across the elbows.Mild bilateral upper extremity sensory neuropathy.Patient underwent x-ray of wrist.Impression: mild nonspecific joint space narrowing at the radiocarpal joint.No acute osseous pathology identified.On (b)(6) 2013, (b)(6) 2014, (b)(6) 2015, , patient presented for office visit for medication refill.On (b)(6) 2013, patient presented with complaints of worsening low back pain which is going down right leg again, patient was having difficulty in moving from one position to other while in bed or in chair.On (b)(6) 2013, patient presented for office visit with complaints of hypertension, chronic back pain and bipolar disorder.Patient also needed medication refill.On (b)(6) 2013, patient presented for office visit with complaints of headache for about two weeks, pain is on right temple area going to the post auricular area.Light sometimes makes the pain worse.On (b)(6) 2013, patient presented for follow-up on hypertension.On (b)(6) 2014, patient presented for office visit with complaints of chronic pain in neck and back, schizophrenia and lower urinary tract symptoms.On (b)(6) 2014, patient presented with complaints of foot pain, headache, congestion, dental problem and letter for school or work.On (b)(6) 2014, patient presented for follow-up on hypertension and chronic pain.Patient reported numbness in hands.On (b)(6) 2015, patient presented for follow-up on hypertension, back pain, cough and congestion.Back pain radiates down legs.

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; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5512313
• MDR Text Key: 40781190
• Report Number: 1030489-2016-00752
• 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: 02/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7510200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2016
• 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): Other