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); Swelling (2091); Tingling (2171); Stenosis (2263); Inadequate Pain Relief (2388); Numbness (2415); Ambulation Difficulties (2544); Nerve Proximity Nos (Not Otherwise Specified) (2647)

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.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.

Event Description

It was reported that on (b)(6) 2008, the patient underwent tlif from vertebrae l4 to l5 wherein rhbmp-2/acs was implanted from a tra nsforaminal approach in the disc space.The rhbmp-2 collagen sponge was placed outside a cage (i.E in the disc space).Post-op, the patient complained of increasing severe pain in low back, buttocks, hips and groin, with some radiating pain the right thigh.Severe pain and symptoms lead the patient to undergo a revision surgery on (b)(6) 2011, where surgeon noted nerve root impingement.The patient continued to experience back pain, radiculopathy into his right leg, numbness and tingling in his lower back, swelling from lower back to his buttocks, muscle spasms and sciatic nerve pain.The patient experienced difficulty in sitting, standing and walking, and required occasional use of a cane.These injuries prevent patient from practicing and enjoying the activities of daily life.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient presented with the following pre-op diagnosis: lumbar spondylolisthesis with a facet cyst causing lumbar stenosis left l4-5.Patient underwent following procedures: lumbar laminectomy, medial-third facetectomy and foraminotomy, left side along with decompression of dural sac; l4-5 interbody fusion through transforaminal-lumbar interbody-fusion approach; pedicle-screw instrumentation l4-5; insertion of intervertebral cage, 10 mm size; local bone graft augmented with rhbmp-2/acs allograft material for purposes of fusion.As per operative notes, ¿annulotomy was made with a scalpel.Shavers were introduced, up to size 10 shaver, and a 10-size trial was introduced, fitting the best.At this stage, the endplates were decorticated using curets.Bone graft augmented with rhbmp-2 allograft was then packed into the disk space followed by a 10mm peek cage.Finally compression was applied over a 5.5 titanium rod once the distraction was removed.¿ no intra operative complications were reported.

• 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: 5553707
• MDR Text Key: 42031024
• Report Number: 1030489-2016-00999
• 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: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2016
• 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: 04/09/2018
• 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): Required Intervention