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 Muscle Spasm(s) (1966); Neuropathy (1983); Pain (1994); Swelling (2091); Weakness (2145); Sleep Dysfunction (2517); 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.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

Levels implanted: l4-l5 it was reported that on (b)(6) 2011, the patient underwent transforaminal lumbar interbody fusion and posterolateral fusion surgery.Reportedly, rhbmp-2/acs was used in this surgery.Post-op, the patient suffered from increasing low back pain, radiating pain into the buttocks and legs, and weakness involving her right leg.Patient continued to experience constant and severe lower back pain and stiffness, with pain radiating across her hips and down her legs, muscle spasms, pain in her toes, swelling in her legs and ankles, and bowel issues.Patient could not sit or stand for any length of time, experienced difficulty sleeping, experiences difficulty walking, required use of a cane on occasion, and rarely leaves her home due to pain.These serious 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 was pre-operatively diagnosed with 1) degenerative spondylolisthesis l4-5 2) left greater than right leg pain 3) back pain less than leg pain and underwent the following procedures: 1) transforaminal lumbar interbody fusion l4-5 utilizing 2) structural allograft mixed with autologous bone chips mixed with autologous bone chips mixed with bmp sponge 3) bilateral posterolateral fusion at l4-5 utilizing 4) the [asclip] instrumentation 5) fusion utilizing autologous bone chips as well as bmp sponge as well as integra demineralized bone matrix 6) decompression l4-5 nerve roots bilaterally.As per op-notes,¿ again, as i previously dictated, not withstanding this, because of the patient's pain was overwhelmingly leg and because the patient had a substantial slip at 4-5, i decided to just limit the surgical procedure today to the 4-5 interspace and do our transforaminal lumbar interbody fusion and reduction and decompression.We proceeded to place pedicle screws in the pedicles of 4 and 5 bilaterally.We decorticated the transverse processes of 4 and 5.We composed a mixture of autologous bone as well as integra demineralized ban matrix as well as bmp sponge.We rolled in like a sausage or bracciola, and then we placed it between the decorticated transverse processes of 4 and 5 bilaterally.We had previously placed our pedicle screws.¿ 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: 5767804
• MDR Text Key: 48711773
• Report Number: 1030489-2016-01960
• 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: 03/06/2018

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: 7510200
• Device Lot Number: M110664AAP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/08/2016
• Initial Date FDA Received: 07/04/2016
• Supplement Dates Manufacturer Received: 06/08/2016; 02/26/2018
• Supplement Dates FDA Received: 09/23/2017; 03/06/2018
• 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): Other