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

Catalog Number 7510600

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

Patient Problems Incontinence (1928); Muscle Spasm(s) (1966); Neuropathy (1983); Pain (1994); Swelling (2091); 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.Multiple products 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 the patient underwent spinal fusion surgery on the lumbar region of her spine from vertebrae l4 through s1.The rhbmp-2 collagen sponge was used to fuse more than one level of the spine.The rhbmp-2 collagen sponge was placed outside a cage (i.E.In the posterolateral gutters).Post-op, patient reportedly had "increasingly severe low back pain, pain radiating to her buttocks, groin pain, pain and radiculopathy into her left leg down to her heel, numbness in her heel, and bladder incontinence"."imaging has shown migration of the cage extending into the canal at l4/5 and pressing on the right l5/nerve root"."patient continues to experience chronic and severe lower back pain radiating into her groin and down her legs, a burning sensation in her buttocks and tops of her feet, muscle spasms, numbness and tingling in legs and feet, pain in her inner thighs, and constant swelling in back.Patient experiences difficulty sitting, standing and walking, and requires occasional use of a cane to assist in ambulation.".

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 on (b)(6) 2005, the patient was pre-operatively diagnosed with degenerative disc disease, l4-5 and l5-s1 and underwent the following procedures: l4-5 and l5-s1 laminectomy, discectomy and posterior lumbar interbody fusion, placement of cages, l4-5 and l5-s1, posterolateral arthrodesis, l4 through s1, pedicle screw stabilization ,l4-s1.As per op-notes,¿ the endplates were decorticated with shavers and curettes.A 10 x 26 mm cage was then filled with a rhbmp2 containing sponge and then placed into the l5-s1 disc space.There appeared to be a tight fit.The thecal sac was then retracted from right-to-left at the l4-5 level.The epidural fat and draining veins were coagulated with bipolar cautery.The disc annulus was incised, and this material was removed.The end plates were decorticated, and a 10 mm x 26 mm cage was placed at the l4-5 level.There appeared to be a tight fit.X-rays were obtained which confirmed proper localization and placement of the cages.¿ 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: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5767796
• MDR Text Key: 48712760
• Report Number: 1030489-2016-01954
• 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: 11/13/2017

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 Catalogue Number: 7510600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/15/2016
• Initial Date FDA Received: 07/04/2016
• Supplement Dates Manufacturer Received: 06/15/2016; 10/30/2017
• Supplement Dates FDA Received: 09/23/2017; 11/13/2017
• 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