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); Loss of Range of Motion (2032); Distress (2329); Injury (2348); Disability (2371); Ambulation Difficulties (2544); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(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 or about (b)(6) 2010, the patient underwent lumbar interbody fusion surgery at l4-l5.Posterior lumbar interbody fusion (plif) and posterolateral fusion (plf) was performed on the patient at level l4-l5 using a surgical cage made of polyeth eretherketone (peek).The fusion cage was packed with bone morphogenetic protein (bmp), which was soaked into a collagen sponge (bmp/sponge).Bmp was also placed anteriorly in the disc space prior to insertion of the cage.Following his surgery, the patient initially improved, but subsequently developed additional new and/or worse pain, suffering, symptoms and disability.Specifically, the patient has experienced progressive disabling pain in his lower back, radiating to his legs.As a result, he has difficulty sitting, bending, lifting and walking.The patient has suffered from severe injuries and damages, including but not limited to severe pain, great emotional distress, and mental anguish.

Manufacturer Narrative

Add'l info: (b)(4).

Event Description

It was reported that on (b)(6) 2010, patient presented with pre operative diagnosis of lumbar l4-5 degenerative disk disease and int ractable back and leg pain underwent bilateral inferior laminotomy l4, bilateral superior laminotomy l5 with left facetectomy for decompression of bilateral l4 and l5 nerve roots, l4-5 arthrodesis using interbody graft, using peek cage with morselized local bone graft and rhbmp-2/acs, transpedicular hardware at bilateral l4 and l5, posterior lateral fusion using bmp and compression resistance matrix.Per operative report: ¿.A midline incision was made from spinous process of l3 through l5.L4 and l5 level were confirmed using x-ray.Transpedicular screws were placed in l4 and l5 bilaterally with excellent bone purchase.Transverse processes were decorticated bilaterally.Morselized local bone mixed with rhbmp-2/acs was inserted into the disk space.This was followed by the peek interbody cage that was filled with bmp and morselized local bone graft.After the peek cage was inserted, local bone graft without the bmp was tamped into the interbody space.The posterior lateral fusion was completed with bmp and compression resistant matrix.The transpedicular screws were connected with titanium rod placed under compression and the caps were placed and tightened bilaterally.The end caps were sheared off.¿.

• 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; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5403539
• MDR Text Key: 37303481
• Report Number: 1030489-2016-00370
• 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: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2016
• 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: 03/20/2017
• 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
• Patient Age: 41 YR