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

Catalog Number 7510400

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

Patient Problems Incontinence (1928); Neuropathy (1983); Pain (1994); 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.

Event Description

It was reported that on (b)(6) 2006, patient was admitted to the facility, where the patient underwent spine fusion surgery using rhbmp-2 on the lumbar region of his spine from vertebrae l4 to l5.The rhbmp-2 collagen sponge was placed outside a cage (i.E., in the disc space and transverse processes).Post-op, patient had increasing low back pain, with radiating pain into his right buttock, groin and thigh.Severe pain and symptoms ultimately compelled patient to undergo a risky, painful and costly revision surgery, due to bony overgrowth and suspected nonunion.

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.

Event Description

On (b)(6) 2008, patient again underwent fusion surgery on the lumbar region of his spine from vertebrae l3 to l5.The rhbmp-2 collagen sponge was placed outside a cage (i.E., in the posterolateral gutters).After this surgery, patient experienced a brief period of improvement, following again by increasingly severe low back pain, with radiating pain to his buttocks, thighs and groin.Patient continues to experience constant lower back pain, with radiating pain to his buttocks and left leg, numbness in his left foot, bladder and bowel incontinence, and sexual dysfunction.He is unable to sit, stand, walk or drive for long periods of time.

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) crohn¿s disease 2) isthmic spondylolisthesis at l4-l5 3) severe disc degeneration l3-l4, l4-l5 4) suspected non-union at l4-l5 5) status post prior laminectomy at l4 on left and posterolateral spinal fusion and posterior pedicle screw fixation at l4-l5 6) continued back pain and underwent the following procedures: 1) removal of pedicle screw implants at l4-l5.2) exploration of fusion at l4-l5.3) revision pedicle screw implants l3 to l5 (6 screws, 2 rods).4) posterolateral spinal fusion l3-l4 and l4-l5.5) 10 ml local bone graft, 80 mg bone morphogenic protein, 50 ml fresh frozen femoral head, 8 fajitas 2 mg bone morphogenic protein to 1 ml water concentration.As per op-notes, ¿we placed the screws at l3, l4 and l5 on both sides.Then we decorticated more.We then cut and contoured two 5.5 stainless steel rods appropriately.Preliminarily engaged them, and then took them out.We then placed the bone morphogenic protein.We placed the rods, tightened down the set screws and broke them off.We decided not to use any crosslink.The construct was extremely secure.We decided to use combination of bone morphogenic protein and fresh frozen femoral head as the first go around.We used bone morphogenic protein on the crm sponges but we were not entirely happy with the fusion mass.The bone potion was 80 mg bone morphogenic protein, 50 ml fresh frozen femoral head put into 8 fajitas which are the collagen sponges.2 mg bone morphogenic protein to 1 ml water and then the 8 fajitas or rolled sponges were soaked for 45 minutes before we cut them into a stew and packed them tightly into the posterolateral gutters on both sides from l3 to l5".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: 5767799
• MDR Text Key: 48712643
• Report Number: 1030489-2016-01958
• 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,Followup
• Report Date: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2010
• Device Catalogue Number: 7510400
• Device Lot Number: M110703AAA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/12/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/31/2007
• 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