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

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

Patient Problems Pain (1994); Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

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 spine fusion surgery in the cervical region of his spine from vertebrae c6-7.Reportedly, the patient was implanted with rhbmp-2/acs in this surgery.Allegedly, "the patient continues to suffer from chronic pain." patient alleges unspecified injury due to the use of rhbmp-2.

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 failed fusion with loose hardware and discogenic back pain and underwent the following procedures: 1) complex revision of the cervical spine with increased difficulty due to scar.2) removal of hardware anteriorly at c6-7 and removal of interbody hardware at c6-7.3) redo fusion at c6-7 with cornerstone allograft (6mm x 11mm) with crushed cancellous bone, extra extra bmp and plate 23mm.4) disc replacement at c5-6.As per op-notes,¿ we were able to peel this back and deeper there appeared to be more typical peudoarthrosis scar tissue but this entire process was removed.Once we did this, we continued to shape the space.We prepared an extra extra small kit of bone morphogenic protein for protocol and placed it on the back table and allowed to cure.Once we shaped the space, we decompressed and then we backed to the posterior aspect of the spine and we placed a bed of deep crushed cancellous allograft followed by a portion of bmp.We in total used only 1/3rd of a small extra extra small sponge.¿ 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: 6207982
• MDR Text Key: 63359845
• Report Number: 1030489-2016-03549
• 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: 03/01/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2016
• Initial Date FDA Received: 12/28/2016
• Supplement Dates Manufacturer Received: 12/05/2016; 02/12/2018
• Supplement Dates FDA Received: 09/28/2017; 03/01/2018
• 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