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

Catalog Number 7510400

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

Patient Problems Neuropathy (1983); Injury (2348); Joint Swelling (2356); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

It was reported that, the patient underwent spine fusion surgery on the lumbar region of his spine from vertebrae l4 to s1.The patient was implanted with rhbmp-2/acs, which was applied from a transforaminal and posterolateral approach and was placed outside a cage (in the disc space).Post-op, the patient reportedly suffered from progressively worsening low back pain with radiculopathy in his lower extremities.The patient continued to experience chronic low back pain with radiculopathy into his lower extremities, including numbness in his right leg and swelling in his ankles.He also experienced difficulty in standing, walking and performing daily life activities.The patient allegedly suffered serious and permanent injuries.

Manufacturer Narrative

(b)(4).Neither the device nor applicable medical records or imaging studies were returned nor provided for evaluation.

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 on: (b)(6) 2010: the patient presented with the following pre-op diagnoses: radiculopathy l5 and s1 bilaterally and underwent the following procedures: thoracolumbar interbody fusion, l4-l5 and l5-s1; use of peek interbody cages at l4-l5 and l5-s1; posterolateral fusion l4 through s1 in which autologous bone was also used.As per the operative notes,¿ the disk space was packed with bone as well as the bmp (bone morphogenic protein) rolled up with some autologous bone.The rest of the bmp was then put into the peek cage itself with some autologous bone.This was done on the two levels.A 70-mm rod was then laid on the left side and a 60-mm rod was laid on the right side.Compression was accomplished and all the screws were then finally tightened to 12 mm of torque ¿.No intra-operative complications were reported.

• 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: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4853561
• MDR Text Key: 18093153
• Report Number: 1030489-2015-01214
• 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: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2013
• Device Catalogue Number: 7510400
• Device Lot Number: M110905AAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/26/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/07/2010
• 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