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

Catalog Number 7510100

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

Patient Problems Ossification (1428); Dysphagia/ Odynophagia (1815); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Neck Pain (2433); Sleep Dysfunction (2517)

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 on (b)(6) 2012, the patient underwent an anterior cervical fusion surgery on the cervical region of her spine from vertebrae c3 to c7."the rhbmp-2 collagen sponge was used to fuse more than one level of the spine".Post-op patient allegedly had "increasingly severe neck pain and radiculopathy into her upper extremities."."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.".Reportedly, the patient "continues to experience chronic neck pain.She is unable to bend her head down, turn her head to the side, sit up for extended periods, and her neck feels heavy.She also experiences trouble swallowing and sleeping.Patient requires a health care aide to assist her with activities of daily living.".

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) 2012, the patient presented with following pre-op diagnosis: cervical spondylosis with myopathy; history of tobacco abuse; diabetes; hypertension; she underwent following procedures: anterior cervical corpectomy of c4; anterior cervical diskectomy and fusion at c-6; anterior cervical diskectomy and fusion at c6-7; anterior cervical plating, c3 through c7 with biomet maxan green plate with fixed angle screws at all levels; anterior cervical fusion at c3-4; anterior cervical fusion additional level c4-5; structural fresh-frozen allograft plus local autograft plus demineralized bone matrix plus extra small rhbmp-2 grafting; microscope visualized corpectomy.As per operative notes,¿ decorticated the endplates, took a structural allograft that was paced with local autograft, demineralized bone matrix, and half an extra-small basic metabolic panel, tamped it in place, and put in additional local autograft at the uncinate and turned our attention to 5-6 and 6-7.This was removed and then after we went ahead and did a thorough diskectomy and we did a thorough decompression, surgeon reconstructed with structural allograft that was packed with the remaining portion of the rhbmp-2 split evenly between the two levels, along with local autograft.Surgeon tamped it in and then took a longitudinal slotted graft and put it on the left side at t6-7 and then added local autograft and demineralized bone matrix.¿ 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: 6025335
• MDR Text Key: 57249101
• Report Number: 1030489-2016-02874
• 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: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2012
• Device Catalogue Number: 7510100
• Device Lot Number: M111105AAC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/30/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/09/2011
• 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