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 Incontinence (1928); Neuropathy (1983); Tingling (2171); Numbness (2415); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4) (persistene back pain).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.Products from multiple manufacturers were implanted 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.

Event Description

It was reported that on (b)(6) 2009, patient underwent a posterior lumbar fusion surgery from l4- l5 using rhbmp-2/acs.During the surgery posterior approach was used.The rhbmp-2 collagen sponge was placed outside a cage (i.E., in the posterolateral elements).Patient's post-operative period has been marked by a period of improvement, followed by increasing low back pain, radiculopathy, and urinary issues.Patient's urinary urgency/frequency symptoms ultimately necessitated the installation of an interstim system device.Patient continued to experience extreme lower back pain, with radiculopathy into her legs, including numbness and tingling from her lower back to her toes, swelling in her low back, and urinary incontinence.She requires use of a walker or cane around the house, and sometimes a wheelchair.She requires a scooter or wheelchair for extended outings.These serious injuries prevent patient from practicing and enjoying the activities of daily life that she enjoyed pre-operatively.

Event Description

It was reported that on: (b)(6) 2009: the patient was pre-operatively diagnosed with juxta fusional spinal stenosis l4-5, status post fusion l5-s1 and underwent the following procedures: hardware removal, explore fusion l5-s1.Lumbar laminectomy l4-l5.Posterior spinal fusion with bone morphogenic protein and mosaic l4-l5.Spinal instrumentation with expedium instrumentation l4 to s1.As per the operative notes, ¿the posterolateral elements were decorticated with the high speed drill.Bone morphogenic protein and m osaic were packed on the posterolateral elements.Then 6 by 40 mm expedium screws were placed in the pedicles of l4 bilaterally and 7.5 by 40 mm screws were placed in the pedicles of s1 bilaterally.The appropriate sized pre-bent rod was chosen and tightened down.All connections were checked and double checked.¿.

Manufacturer Narrative

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: 5543595
• MDR Text Key: 41721416
• Report Number: 1030489-2016-00898
• 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: 08/07/2017

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 Expiration Date: 09/01/2011
• Device Catalogue Number: 7510400
• Device Lot Number: M110803AAN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/10/2016
• Initial Date FDA Received: 04/04/2016
• Supplement Dates Manufacturer Received: 08/07/2017; 08/07/2017
• Supplement Dates FDA Received: 08/18/2017; 09/20/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/23/2009
• 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