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 Dyspnea (1816); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Neck Pain (2433); Shaking/Tremors (2515); 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.

Event Description

It was reported that the patient underwent spinal fusion surgery on the cervicothoracic region of her spine from vertebrae c2-c3 and to c7-t1 using rhbmp2 on (b)(6) 2006.The rhbmp-2 collagen sponge was used to fuse more than one level of the spine.Post-op, patient reportedly had "increasingly severe neck pain, with pain and radiculopathy into her upper extremities.Patient continues to experience chronic neck pain, with pain radiating to her shoulders, tremors in her arms and hands, and limited range of motion in her neck.Patient is unable to look up, experiences difficulty breathing, and feels her neck is continuously pushed forward and out of alignment.".

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 presented with following pre-op diagnosis: cervical pseudoarthrosis c3 through c7, status post anterior cervical diskectomy and fusion c3 through c7 at an outside institution in the remote past by a different surgeon, and adjacent level breakdown c7-t1 with persistent stenosis at the c4 and c7-t1.She underwent the following procedures: 1.Complex posterior cervical laminectomy of c4.2.Complex posterior cervical partial laminectomy of c7 and partial laminectomy of t1.3.Complex posterior cervical fusion c2-c3.4.Complex posterior cervical fusion at additional levels c4, c5, c6, c7, and t1.5.Complex segmental lateral mass and pedicle screw instrumentation c2-t1.6.Spinous process c2-c3.7.Structural allo patellar grafting.8.Local autologous bone grafting.9.Microscope visualized laminectomy and fusion.As per the operative notes, ¿allo of patella was taken and cut down in half, and wired in at c2-c3 and c7-t1, and a large bone morphogenic protein that was split evenly between the two sites was adde d".No intra-operative complications were reported.

• 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: 5781635
• MDR Text Key: 49124339
• Report Number: 1030489-2016-02031
• 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: 03/28/2018

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 Catalogue Number: 7510800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/15/2016
• Initial Date FDA Received: 07/11/2016
• Supplement Dates Manufacturer Received: 06/15/2016; 03/12/2018
• Supplement Dates FDA Received: 09/23/2017; 03/28/2018
• Was Device Evaluated by Manufacturer?: No
• 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