MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC.; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Neuropathy (1983); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Report source: (b)(6) 2009 (year valid).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.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported via patient call that patient has cages implanted at l5-s1 which are too small from a surgery in 2009.Patient said he asked for revision surgery and someone did fasciectomy as a result of which joints started to get inflamed because the calcium in the bone growth where you get stability after the fusion it starts to cut on the nerve they do a little foraminotomy.Patient complained of neuropathy in his hands.In 2013 his bones were getting weak and he asked for revision.Patient states he has "subsequent hypertrophy" which started at his lumbar in 2013 and now its in the cervical area.Patient suffered due to non-malignant pain as well.

• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC.; 1800 pyramid place; memphis TN 85281
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC.; 1800 pyramid place; memphis TN 85281
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 8486005
• MDR Text Key: 141008297
• Report Number: 1030489-2019-00394
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/06/2019
• 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
• Patient Age: 53 YR