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 Muscle Spasm(s) (1966); Neuropathy (1983); Pain (1994); Tingling (2171); Numbness (2415); Ambulation Difficulties (2544)

Event Type  Injury  

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.

Event Description

It was reported that on (b)(6) 2013, patient was admitted to the facility,where surgeon performed spine fusion surgery involving rhbm2 on the lumbar region of his spine from vertebrae l3 to l4.The rhbmp-2 collagen sponge was placed outside a cage (i.E., in the transverse process facet complex, laminar region, lateral pars and medial transverse process).Post-op, "patient continued to experience chronic lower back pain and muscle spasms, extreme radiating leg pain, and numbness and tingling in his legs and feet.Patient experiences difficulty sitting, standing and walking for extended periods, and uses a walker and electric wheelchair for longer distances, to assist in ambulation.A second revision surgery has been recommended".

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: 6207987
• MDR Text Key: 63357782
• Report Number: 1030489-2016-03557
• 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: 12/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 12/05/2016
• Initial Date FDA Received: 12/28/2016
• Supplement Dates Manufacturer Received: 12/05/2016
• Supplement Dates FDA Received: 09/27/2017
• 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