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 Neuropathy (1983); Pain (1994); Burning Sensation (2146); 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) 2012, the patient underwent a two-stage anterior lumbar interbody fusion and posterior fusion surgery respectively on the lumbar region of his spine from vertebrae l4 to l5.Reportedly "the rhbmp-2 was used in the surgery"."the rhbmp-2 collagen sponge was placed outside a cage (i.E.In the posterior elements).".Post-op the patient allegedly had " increasing lower back pain, with pain and radiculopathy in his lower extremities.".Reportedly the patient "continues to experience constant burning and stabbing pain in his lower back, with pain radiating down to his buttocks and legs, numbness and tingling down the back of his legs and front of his left leg, numbness in his left hip.He experiences difficulty sitting, standing and walking, and requires a cane for assistance in ambulation.

Event Description

It was reported that on: (b)(6) 2012: the patient was pre-operatively diagnosed with l4-l5 annual tear, with instability and underwent the following procedures: l4-l5 anterior lumbar interbody fusion via direct lateral approach.Placement of an interbody cage.Placement of bone morphogenic protein.As per op-notes, ¿disk preparation was performed.There was much gritty disk material, consistent with the prior discectomy.The endplates were curetted to bleeding bone.The opposite annulus was released to stay shaped and fitted to a size 10 x 50 x 6-degree x 22 mm anterior-posterior dimension peek cage, prefilled with a medium kit of bone morphogenic protein.Good fit and fill, restoration of lordosis, foraminal height was achieved.¿ patient tolerated the procedure well without any intraoperative complications.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6019991
• MDR Text Key: 57053359
• Report Number: 1030489-2016-02855
• 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,Followup
• Report Date: 07/31/2017

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: 09/19/2016
• Initial Date FDA Received: 10/12/2016
• Supplement Dates Manufacturer Received: 07/31/2017; 07/31/2017
• Supplement Dates FDA Received: 08/28/2017; 09/25/2017
• 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