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 Pain (1994); Weakness (2145); Stenosis (2263); Anxiety (2328); Depression (2361); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the r eported event.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient underwent oblique lateral interbody fusion and posterior fusion surgery at l2-3 due to intervertebral disc degeneration and lumbar low back pain.At approximately 18 months post-op, patient symptomatic and showing signs of an inflammatory response (muscle aches, weakness, joint pain, back pain, difficulty walking, weakness and numbness, depression and anxiety).Surgeon describes response as ¿over-exuberant osteoclast activation from bone morphogenetic protein (bmp)¿.Additionally, there have been no reports of indications of any active infection from the time of implantation.On (b)(6) 2017: patient underwent a posterior pedicular biopsy and redo l2-3 laminectomy for recurrent stenosis and a lyric lesion in his vertebra.Result: wound was normal, cultures grew no organisms and had negative gram stain.

• 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: 8576888
• MDR Text Key: 143935165
• Report Number: 1030489-2019-00508
• Device Sequence Number: 1
• Product Code: NEK
• UDI-Device Identifier: 00681490843782
• UDI-Public: 00681490843782
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 7510200
• Device Lot Number: M111613AAH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/06/2017
• 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; Required Intervention
• Patient Age: 47 YR
• Patient Weight: 91