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

Catalog Number 7510600

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

Patient Problems Muscle Spasm(s) (1966); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Tingling (2171); Numbness (2415); Sleep Dysfunction (2517); Ambulation Difficulties (2544)

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.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

Levels: l4-s1 it was reported that on (b)(6) 2007, the patient underwent posterior lumbar fusion surgery from vertebrae l4 to s1.Reportedly, rhbmp-2/acs was used in this surgery.The rhbmp-2 collagen sponge was used to fuse more than one level of the spine.Post-op, the patient suffered from increasing severe back pain, with associated radiculopathy in his lower extremities.Patient continued to experience extreme lower back pain, with pain radiating to his hips,numbness and tingling in his legs and feet, and muscle spasms.He experienced limited mobility, and difficulty sitting, standing, walking, and sleeping.These serious injuries prevent patient from practicing and enjoying the activities of daily life.

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 the patient was pre-operatively diagnosed with status post fusion l5-s1, juxtafusional stenosis and instability of l4-5, pseudarthrosis l5-s1 with instability and chronic lumbar pain.The patient underwent the following procedures: 1) hardware removal, explore fusion l5-s1.2) bilateral lumbar laminectomy of l4-5.3) foraminotomy l4-5.4) posterior spinal fusion with bone morphogenic protein and instrumentation l4 to s1.As per op-notes, "we identified the previously placed instrumentation as well as the spinous process and transverse process of l4.Hardware was removed with significant amount of reactive tissue around the hardware.Following this, small foraminotomy and laminotomy at l4-5 was performed, resecting portions of the medial facets to facilitate decompression and to prevent any type of nerve root impingement as we placed the instrumentation.Following this, we sounded and tapped the pedicles at l4 and then decorticated the transverse processes.We placed screws at l4 and s1, and bone matrix soaked in bone morphogenic protein in the intervening space after decortication of the bone.¿ the patient tolerated the procedure well without any intraoperative complications.

• 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: 5767884
• MDR Text Key: 48712169
• Report Number: 1030489-2016-01964
• 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: 01/16/2018

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 Expiration Date: 05/01/2009
• Device Catalogue Number: 7510600
• Device Lot Number: M110601AAA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/08/2016
• Initial Date FDA Received: 07/04/2016
• Supplement Dates Manufacturer Received: 06/08/2016; 12/18/2017
• Supplement Dates FDA Received: 09/23/2017; 01/16/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/28/2006
• 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