MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Catalog Number 7510200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); 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.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.

Event Description

It was reported that on (b)(6) 2010, patient underwent transforaminal lumbar interbody fusion and posterolateral fusion from vertebrae l4 to s1.Reportedly, the patient was implanted with rhbmp-2/acs in this surgery.The rhbmp-2 collagen sponge was placed outside a cage (i.E., in the disc space and over the transverse processes).Allegedly, "patient's post-operative period was marked by a period of improvement, followed by progressively increasing low back pain.Severe pain and symptoms ultimately compelled the patient to undergo a revision surgery on (b)(6) 2014.The patient continues to experience constant lower back pain, numbness in the lower back area, pain that radiates around to his stomach and down his legs, numbness and tingling from the knee down, and swelling in his right leg.Furthermore, patient has bowel, bladder and sexual dysfunction, limited mobility, and difficulty sitting, standing and walking.He requires daily use of a cane and electric wheelchair to assist in ambulation.".

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.

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2010, the patient was pre-operatively diagnosed with l4-l5 and l5-s1 degenerative disc disease with disc herniation and lumbar stenosis and underwent the following procedures: l4-l5 and l5-s1 transforaminal lumbar interbody fusion with autograft, placement of biomechanical device at l4-l5 and l5-s1, l4-s1 posterior lateral transverse process fusion with autograft, bilateral l4-s1 pedicle screw/rod instrumentation, l4-l5 decompressive laminectomy, harvesting of local bone graft, intraoperative neurophysiological monitoring, and intraoperative fluoroscopy.As per op-notes,¿ then the decompression was carried over to the right side to ensure that the nerve root was well decompressed on that side also.The disk space was opened there and the same procedure repeated.The same was done at l5-s1 level.Then, since the lamina had been preserved, a lamina spreader could be used and different size trials were used.It was decided to go with a 12 mm in height implant.This was depuy carbon fiber/peek implant that was a 12 mm in height and 23 mm in length at the l4-l5 level.This was filled with the patient's own bone and vitoss tricalcium that had been soaked in bone morphogenic protein.The disk space was filled with the morcellized bone from the decompression along with the vitoss tricalcium and bone morphogenic protein.The spacer was impacted into the space under fluoroscopic guidance, and once it was in good position it was detached from its inserter.The same was done at the l5-s1 level with the same material placed in the disk.¿ the patient tolerated the procedure well without any intraoperative complications.

• 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: 6207958
• MDR Text Key: 63359258
• Report Number: 1030489-2016-03527
• 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: 11/10/2017

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
• Device Expiration Date: 07/01/2013
• Device Catalogue Number: 7510200
• Device Lot Number: M110915AAP
• 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; 10/23/2017
• Supplement Dates FDA Received: 09/27/2017; 11/10/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/15/2010
• 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