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

Catalog Number 7510800

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

Patient Problems Abdominal Pain (1685); Neuropathy (1983); Pain (1994); Joint Swelling (2356); Numbness (2415); Sleep Dysfunction (2517)

Event Type  Injury  

Event Description

It was reported that the patient underwent 1) decompression laminectomy l3-l4 with redo medial facetectomy and foraminotomies at l4-l5; 2) transforaminal lumbar interbody fusion using peek interbody spacer and rhbmp-2/acs augmented with locally harvested bone graft at l3-l4; 3) posterolateral instrumented stabilization at l3-l4 carried down to the l 4-5 level which had already been fused with pedicular instrumentation.(b)(6) 2008 - incision healing well, no drainage or redness.Complaints of low abdominal pain.All lab work is within normal limits.Cat scan of abdomen/pelvis order.(b)(6) 2008 - patient reported unable to sleep with right leg going numb and having a pulsation feeling behind his right knee.Patient treated with medication.(b)(6) 2009 - leg and low back pain worsening.Patient treated with pain medication.Repeat mri of the lumbar spine ordered.(b)(6) 2009 - right leg pain and chronic problems including back pain.(b)(6) 2010 - patient reported swollen left knee for the past two days, possible infection.(b)(6) 2010 - patient reported chest pain/sharp intermittent.(b)(6) 2010 - patient reported a call onto left arm causing pain.Possible rotator cuff tear.(b)(6) 2011 - patient reported to emergency department for stepping on a (b)(6) 2011- patient reported to the emergency department with right hip and arm pain for the past 3-4 months.(b)(6) 2014 - patient reported to the emergency room with right knee pain for the past 4 days without trauma and chronic back pain with radiculopathy.

Manufacturer Narrative

Concomitant products: pedicle instrumentation, interbody spacer (implant: (b)(6) 2008).(b)(6).(b)(4).Neither the device nor applicable imaging study films 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.

• 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: 4247014
• MDR Text Key: 5109098
• Report Number: 1030489-2014-04384
• 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
• Report Date: 10/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2010
• Device Catalogue Number: 7510800
• Device Lot Number: M110614AAG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/13/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/22/2008
• 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
• Patient Weight: 107