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 Problem Injury (2348)

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.Although it is unknown if the device contributed to the reported event, we are filing this mdr for notification purposes.

Event Description

It was reported that: on (b)(6) 2009, the patient presented with classic, progressive and disabling mechanical back pain and neurogenic claudication as well as lumbar radiculopathy.The patient underwent anterior retroperitoneal exposure of the lumbar spine, l4-5 microlumbar discectomy, l4-5 anterior lumbar interbody fusion using 12 mm x 13 degree polyether etherkeytone spacer filled with allograft, bone graft and autologous marrow and bone morphogenic protein sponges from spine 360, l4-5 anterior lumbar locking plate 21 mm with 25 mm screws from spine usa, l5-s1 microlumbar discectomy, l5-s1 anterior lumbar interbody fusion using 10 mm x 13 degree lordotic polyether etherkeytone spacer filled with allograft and bone morphogenic protein sponges, l5-s1 anterior lumbar locking plate 21 mm with 25 mm screws from spine usa, harvest of autologous bone marrow, utilization of fluoroscopic guidance and l4-s1 arthodesis.As per op notes, ¿ a 10 mm lordotic polyether etherkeytone spacer filled with bone morphogenic protein sponges was placed into l5-s1 interspaces without difficulty and gently countersunk.¿ no patient complications were reported.On an unknown date post-op, patient alleged unspecified injuries due to use of rhbmp-2/acs.

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.

• 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: 6208025
• MDR Text Key: 63359446
• Report Number: 1030489-2016-03592
• 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
• Report Date: 12/05/2016

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
• Supplement Dates FDA Received: 09/28/2017
• 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