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 Ossification (1428); Neuropathy (1983)

Event Type  Injury  

Event Description

It was reported that the patient underwent anterior discectomy, decompression, and fusion of l5-s1 using rhbmp-2/acs.Reportedly, sometime post-op, imaging studies revealed that the patient developed bony overgrowth ¿at or near where the rhbmp-2/acs was implanted¿ and nerve compression.The patient has experienced chronic pain and radiculitis.It was also reported that approximately nine months post-op, the patient underwent an anterior cervical discectomy, decompression, micro-foraminotomy, and fusion of c6-c7.Approximately 3 years later, the patient underwent a posterior fusion of c5-c6-c7 with lateral mass instrumentation.

Manufacturer Narrative

(b)(4).Neither the device nor applicable imaging study films or patient medical records were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Products from multiple manufacturers were implanted/used during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.

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

It was reported that, on (b)(6) 2009, patient underwent following procedure: complete anterior retroperitoneal discectomy and decompression l5-s1; placement of carbon fiber interbody spacer filled with bone morphogenic protein (bmp) l5-s1; anterior arthrodesis, with plate, l5-s1.Pre-op and post-op diagnosis: l5-s1 severe disk space collapse, degenerative disk disease and stenosis.Indications: the patient is a (b)(6) who presents with complaints of severe back and leg pain.His plain x-rays demonstrate severe disk space collapse at l5-s1.Lumbar diskography demonstrated excellent controls with no concordant pain at l3-l4 and l4-l5.His mri demonstrates severe disk space collapse and foraminal stenosis at l5-s1.As per operative notes: ".At this point the disk material was removed at l5-s1.There was very little disk material present in the disk space as it was severely collapsed.A good deal of time was spent restoring normal disk space height.Once i was able to restore normal disk space height i then placed a size 12 carbon fiber, 10-degree interbody spacer filled with bmp.Once this was in position and found to be well-positioned on both anterior-posterior (ap) and lateral fluoroscopy views attention was then directed towards plating.No complications were reported.".

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; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4270853
• MDR Text Key: 5300465
• Report Number: 1030489-2014-04519
• 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,consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2014
• 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
• Date Manufacturer Received: 12/19/2016
• 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