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 Dysphagia/ Odynophagia (1815); Dyspnea (1816); Neuropathy (1983); Loss of Range of Motion (2032); Numbness (2415); Neck Pain (2433)

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

It was reported that on (b)(6) 2007, patient was admitted to the facility, where the patient underwent spine fusion surgery using rhbmp-2 on the cervical region of her spine from vertebrae c3 to c6.The rhbmp-2 collagen sponge was used to fuse more than one level of the spine.The rhbmp-2 collagen sponge was placed outside a cage, in the facet joints.Post-op, patient had increasingly severe neck pain, and associated pain and radiculopathy in her arms.Severe pain and symptoms may compel the patient to undergo a risky, painful and costly revision surgery.Patient continues to experience extreme neck pain, pain radiating down her back and arms, numbness in her fingertips, reduced mobility in her neck, and inability to lift her arms over head.She also experiences difficulty breathing, swallowing and drinking.

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 on (b)(6) 2007, the patient was preoperatively diagnosed with cervical pseudoarthrosis at c4-c5 and c5-c6, status post anterior cervical discectomy and fusion, with spondylosis and adjacent-level breakdown at c3-c4, with radiculopathy.She underwent the following procedures: posterior cervical laminectomy with facetectomy and foraminotomy at the bottom portion of c3 and all of c4 and c5.Posterior cervical fusion, c3-c4.Posterior cervical fusion, additional levels, c4-c5 and c5-c6.Posterior cervical segmental titanium lateral mass screw-rod constructs, c3 through c6, with instrumentation.Local autologous bone plus large bone morphogenic protein with grafting.Microscope visualized laminectomy.As per the op notes: "a midline incision was made and we stripped subperiosteally to expose c3, c4, c5 and c6.Then we did foraminotomies bilaterally at c4-c5 and c5-c6 and on the left side at c3-c4 and then we put in lateral mass screws and did a decompression of c4-c5.The bottom portion of c3 was laminectomized.We elevated the lamina at c4 and c5 and put in small tie mesh plates to hold it in place and then put in lateral mass screws at c3, c4, c5, and c6, 10 mm long, 3.5 mm in diameter; fixed these to rods, and obtained an x-ray, which confirmed that everything was in good position.We then irrigated, decorticated the facet joints, and packed local autograft, along with bone morphogenic protein soaked onto a graft sponge.We torque-tightened all the screws and achieved hemostasis, placed in deep and middle drains, and closed the wound in layers.¿ the patient tolerated the procedure well without any intra-operative 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5767879
• MDR Text Key: 48712096
• Report Number: 1030489-2016-01963
• 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: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2009
• Device Catalogue Number: 7510800
• Device Lot Number: M110605AAJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/24/2007
• 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