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

Catalog Number 7510050

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

Patient Problems Muscle Spasm(s) (1966); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Stenosis (2263); Anxiety (2328); Depression (2361); Numbness (2415); Neck Pain (2433); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Event Description

It was reported by a non-medical professional that the patient underwent an anterior cervical fusion procedure at c4-c6 using rhbmp-2/acs.After reexploration surgery on the same day to rule out hematoma, patient developed severe neck spasm into the right scapula, posterior cervical pain and suboccipital swelling, numbness and pain of the right hand, voice hoarseness, and sore throat.Patient later returned home, but his pain in the right hand and neck did not subside.As a result, patient now has severe stenosis in multiple areas, chronic neck spasms, suboccipital numbness and pain of the right hand, depression, incapacitating pain, suicidal thoughts, anxiety, narcotic dependence from prescribed painkillers, cervical and shoulder myofascial syndromes, and other emotional distress and mental anguish.

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.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient is also having restriction of range of motion in the neck.

Event Description

It was reported that on: (b)(6) 2012: the patient was pre-operatively diagnosed with severe cervical spondylosis at c4-c5 and c5-c6 and underwent the following procedures: two-level anterior cervical discectomy and fusion c4-c5 and c5-c6 using bone morphogenic protein and x-spine peek interbody lordotic cages 7 mm in height at c5-c6 and 6 mm in height at c4-c5 with a 39 mm x-spine anterior titanium plate, and 16 mm variable screws at c6, c5 and c4 bilaterally with intraoperative operating microscope, motor evoked potential monitoring and fluoroscopy.As per op-notes, ¿disk space was sized and a 7 mm lordotic x-spine peek interbody device packed with 0.35 ml of bone morphogenic protein was then countersunk.Distraction pins removed, the holes waxed, and the anterior osteophytes removed with double-action rongeur and the edges waxed.Attention was then turned to the c4-c5 disk.The disk space was again sized after all the cartilage had been clearly removed and this time, a 6 mm lordotic peek interbody device was placed packed with 0.35 ml of bone morphogenic protein.Distraction pins removed, the holes waxed.¿.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 3886796
• MDR Text Key: 4646882
• Report Number: 1030489-2014-02853
• 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,consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/09/2017

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: 10/31/2012
• Device Catalogue Number: 7510050
• Device Lot Number: M111109AAB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/03/2014
• Initial Date FDA Received: 06/20/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; 01/09/2017
• Supplement Dates FDA Received: 12/18/2014; 02/07/2017; 09/28/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/27/2012
• 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