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); Pain (1994); Weakness (2145); Tingling (2171); Cramp(s) (2193); Numbness (2415)

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.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) 2014, patient underwent anterior lumbar interbody fusion from vertebrae l4 to s1.Reportedly, the patient was implanted with rhbmp-2/acs in this surgery.Allegedly, "patient's post-operative period was marked by a period of improvement, followed by progressively worsening low back pain, with associated pain and radiculopathy in his lower extremities.Severe pain and symptoms ultimately compelled the patient to undergo a surgery on (b)(6) 2016.Patient experienced some relief of his symptoms following this second surgery, but continued to experience low back pain and severe left leg pain radiating to his foot.Patient's symptoms have continued to progress, with pain radiating from his low back, down his left buttock, and all the way to his foot.He experiences weakness and cramping in his left leg, numbness and tingling in his left calf and foot, and bladder dysfunction.Patient is unable to sit or stand for extended periods and is therefore unable to continue his profession as a corporate jet pilot.Patient has scheduled a second revision surgery in (b)(6) 2017.".

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

The patient presented with the following pre-op diagnosis: l4-5, l5-s1 degenerative disk disease.The patient underwent the following procedures: combined anterior and posterior l4 to s1 fusion with instrumentation.As per op-notes, ¿a 14 x 12 degree perimeter cage was filled with the appropriate volume of rhbmp-2/acs prepared according to the manufacture's specifications.A 14 x 8 degree peek perimeter cage was filled with the appropriate volume of rhbmp-2/acs and tamped into pace with excellent purchase.¿ 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 USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6208000
• MDR Text Key: 63359538
• Report Number: 1030489-2016-03565
• 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: 06/13/2018

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
• Device Catalogue Number: 7510400
• Device Lot Number: M111302AAV
• 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; 05/14/2018
• Supplement Dates FDA Received: 09/27/2017; 06/13/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/09/2013
• 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): Required Intervention