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

Catalog Number 7510200

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

Patient Problems Neuropathy (1983); Loss of Range of Motion (2032); Cramp(s) (2193); Numbness (2415); Neck Pain (2433); Sleep Dysfunction (2517)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(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

It was reported that on (b)(6) 2008, the patient underwent a spinal fusion surgery on the cervical region of her spine from vertebrae c4 to c7.Reportedly, during the surgery, rhbmp-2/acs was used in the patient.As reported, the patient's post-operative period had been marked by a period of improvement, followed by increasing low back pain, cramping, and associated radiculopathy and numbness in her right leg and foot.Patient's postoperative period following her cervical fusion was marked by increasing neck pain.Patient's symptoms necessitated the installation of an external bone growth stimulator.Radiographic imaging demonstrates bony overgrowth where rhbmp-2 was implanted in patient's cervical spine.Severe pain and symptoms ultimately compelled patient to undergo a revision surgery on (b)(6) 2014.Patient continues to experience extreme neck pain, with pain radiating to her shoulders and down her arms, numbness in her fingertips, limited range of motion when turning her head, and difficulty swallowing.Patient cannot sit or stand for extended periods, and has difficulty sleeping.Further, patient suffers from irritability and depression as a result of her pain and limitations.These serious injuries prevent patient from practicing and enjoying the activities of daily life that patient enjoyed pre-operatively.

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 cervical herniated disc at 4-5, 5-6, and 6-7 with stenosis and underwent the following procedures: partial corpectomy of c4, c5, c6.Fusion of c4-5, c5-6, and c6-7.Autograft locally from the decompression, biomechanical devices x3 (x2 size 8, x1 size 7).Microscope for visualization.As per op-notes,¿ decompression included disc material as well as partial carpectomy as well as a significant portion of disc material which has migrated posterior to the vertebral body.The uncovertebral joints were used as reference points and osteopenia was noted.The decompression was performed and biomechanical bengal devices were placed with local autograft from partial carpectomy as well as bnp.The bnp products were well within the peak and there was no bnp outside of the peak which could come in contact with the soft tissues as well.A small portion of a very small bnp kit was used for all levels leaving almost an entire sponge of the bnp in a left residual after this procedure.¿ 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: 5546546
• MDR Text Key: 41818185
• Report Number: 1030489-2016-00924
• 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: 01/25/2018

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: 06/01/2010
• Device Catalogue Number: 7510200
• Device Lot Number: M110702AAI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/10/2016
• Initial Date FDA Received: 04/05/2016
• Supplement Dates Manufacturer Received: 03/10/2016; 01/08/2018
• Supplement Dates FDA Received: 09/20/2017; 01/25/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/31/2007
• 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