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

Catalog Number 7510400

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

Patient Problems Dysphagia/ Odynophagia (1815); Muscle Spasm(s) (1966); Neuropathy (1983); Loss of Range of Motion (2032); Numbness (2415); Neck Pain (2433); 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.Although it is unknown if the device contributed to the reported event, we are filing this mdr for notification purposes.

Event Description

It was reported that on (b)(6) 2013, patient underwent posterior cervical fusion from vertebrae c3 to c4.Reportedly, the patient was implanted with rhbmp-2/acs in this surgery.The rhbmp-2 collagen sponge was placed outside a cage (i.E., in the facet joints and over the posterior elements).Allegedly, "patient's post-operative period was marked by a period of improvement, followed by progressively worsening neck pain and radiculopathy in his upper extremities.The patient continues to experience chronic neck pain, muscle spasms, limited range motion in his neck, and numbness in his hands.The patient also experiences difficulty swallowing, and difficulty walking.".

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) 2013: the patient was pre-operatively diagnosed with non-union of c3-4, anterior cervical discectomy and fusion and underwent the following operations: posterior instrumentation of c3 and c4 using lateral mass screws and the stryker oasis.Use of morselized cadaveric allograft for arthrodesis.Arthrodesis of the c3-4 level.Use of recombinant human bone morphogenic protein for arthrodesis.Use of the operative microscope.As per operative notes,¿ the sttandard modified magerl technique was used to place lateral mass screws at c3 and c4 bilaterally.These were 3.5 x 14 mm screws from the stryker oasys system.After this, a leksell rongeur was used to resect portions of the bifid spinous processes of c3 and c4.This bone was shaped and fashioned so as to be amenable to packing in the facet joints.Some of the autograft bone as well as some recombinant human bmp2 were packet into the facet joints.The bmp2 was medium sized pack on the acs sponges.This was wrapped around the autograft and we stepped aside of the facet joints.¿ the patient tolerated the procedure well without any intraoperative complications.The patient was also pre-operatively diagnosed with c3-4 nonunion after a previous c3-4 anterior cervical discectomy and fusion and underwent the following procedures: posterior c3-4 instrumentation and fusion.Use of operative microscope.As per operative notes,¿ rods were placed between the screws after the patient had been placed into some extension with the aforementioned tongs.The construct was then secured in place with locking screws.Repeat fluoroscopy at that point showed excellent alignment of the instrumentation construct.We then utilized bone morphogenic protein along with cadaver bone graft.This was placed both into the facet joints bilaterally as well as overlying the lamina and spinous process that had been decorticated with the drill.¿ 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: 6208010
• MDR Text Key: 63358211
• Report Number: 1030489-2016-03573
• 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: 12/27/2017

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: 09/30/2015
• Device Catalogue Number: 7510400
• Device Lot Number: M111301AAF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2016
• Initial Date FDA Received: 12/28/2016
• Supplement Dates Manufacturer Received: 12/05/2016; 12/18/2017
• Supplement Dates FDA Received: 09/27/2017; 12/27/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/03/2013
• 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