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

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

Patient Problems Ossification (1428); Atrial Fibrillation (1729); Neuropathy (1983); Pain (1994); Injury (2348); Cancer (3262)

Event Type  Injury  

Manufacturer Narrative

Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient underwent anterior and posterior decompression at l4-s1, fusion and instrumentation.Post-op, the patient allegedly complained of radiculitis, radiculopathy, chronic pain requiring narcotics, ectopic bone growth or cyst, adjacent segment disease, nerve injury or damage, muscle and soft tissue injury or damage, atrial fibrillation, skin cancer, ossification of adjacent soft tissues of the lumbar spine.Reportedly, the patient also experienced inflammation, post-operatively, had uro-genital pain for about one year after lumbar fusion surgery, erectile dysfunction, stomach hernia attributable to nerve injury, atrial fibrillation secondary to excessive stress from chronic pain, two skin cancers, and severe emotional distress.The patient underwent cryoablation surgery for atrial fibrillation in (b)(6) 2017 and left hip replacement surgery in (b)(6) 2016.

• 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 7659351
• MDR Text Key: 113049208
• Report Number: 1030489-2018-00945
• 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: Patient
• Type of Report: Initial
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/08/2018
• 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