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 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) 2015, patient underwent anterior lumbar interbody fusion surgery from vertebrae l5 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).Allegedly, "patient's post-operative period was marked by a period of improvement, followed by progressively worsening low back, right buttock and bilateral leg pain.Patient continues to experience chronic lower back pain, with associated radiculopathy in his right leg, and numbness in his feet.Patient experiences difficulty sitting, standing and walking for extended periods, and has fallen on several occasions.¿.

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

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

Event Description

It was reported that on: (b)(6) 2015: the patient was pre-operatively diagnosed with l5-s1 pseudoarthrosis and underwent the following procedure: l5-s1 anterior lumbar interbody fusion.As per op-notes,¿ the patient had clip cages in place.It was my original intention to osteomize the cages, place a large single anterior lumbar interbody fusion cage with bmp in it and possibly plate the spine.Because of the exposure, all i could really do was remove the remaining disk material of the space to the right of the cage, out to the right lateral anulus, and that segment was in the center of the area where anteriorly.These areas were meticulously prepared and decorticated.Infuse sponges were then packed into these areas.I did not feel it was safe or worth the risk to cause potential or fatal vascular injury, in trying to do any more than we were able to.¿ 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: 6207957
• MDR Text Key: 63358651
• Report Number: 1030489-2016-03528
• 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: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2016
• Device Catalogue Number: 7510600
• Device Lot Number: M111206AA2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/23/2014
• 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