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); Cerebrospinal Fluid Leakage (1772); Dysphagia/ Odynophagia (1815); Inflammation (1932); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Respiratory Distress (2045); Weakness (2145); Stenosis (2263); Osteolysis (2377); Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Type  Injury  

Event Description

It was reported that the patient underwent an anterior cervical discectomy and fusion surgery using rhbmp-2/acs and a metal cage.The patient's post-operative period was marked by severe pain.Following the surgery the patient suffered from autonomic neuropathy, small fiber neuropathy, peripheral neuropathy, muscle atrophy and nerve damage, inflammatory reactions, chronic radiculitis, retrograde ejaculation, osteolysis (bone resorption), displacement or migration of the spacer cage, pseudoarthrosis, dysphagia, difficulty breathing, difficulty gripping and holding items, and chronic pain.The patient now suffers from injuries, including bone overgrowth causing nerve compression, chronic pain and radiculitis.

Manufacturer Narrative

(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.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.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on: (b)(6) 2009, the patient underwent spinal fusion procedure using rhbmp-2/acs.On (b)(6) 2009, the patient presented with pre-op diagnosis of lumbar cerebrospinal fluid leak and underwent following procedures: re-exploration of previous lumbar laminectomy and extension of the laminectomy to include the superior portion of the l5 lamina.Repair of dural cerebrospinal fluid leak through inspection and fusion.This procedure was done with continuous monitoring of emg and somatosensory evoked potential.On (b)(6) 2009, the patient presented with pre-op diagnosis of cervical spondylosis at c6-c7 with bilateral foraminal stenosis, worse on the left than on the right and underwent following procedures: anterior cervical fusion using a 5 mm cage packed with osteoinductive material and anterior cervical instrumentation using two 15 mm cancellous screws.Per op notes, ¿.The left foramen was tighter than the right, which was consistent with the patient's subjective symptomatology.Once the decompression had been obtained, the interspace was measured under distraction, a 7 mm cage was packed with osteoinductive material , tapped into position and countersunk.Two 15 mm screws were used to secure the cage.¿.

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: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 3652946
• MDR Text Key: 4317900
• Report Number: 1030489-2014-00633
• 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,consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2014
• 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: M110707AAQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/22/2016
• 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; Required Intervention