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

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

Patient Problems Dysphagia/ Odynophagia (1815); Fever (1858); Headache (1880); Pain (1994); Swelling (2091); Numbness (2415); Neck Stiffness (2434); Sleep Dysfunction (2517); 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 per a clinical study that on (b)(6) 2010, the patient underwent anterior cervical discectomy and fusion (acdf) - ex trapharyngeal anterolateral approach on c5-6 and c6-7.The patient was implanted with rhbmp-2/acs in this surgery.Initial diagnosis: acdf for treatment of degenerative disc disease post-op, the patient reported: on (b)(6) 2010, patient reported pain, post-operative; moderate to severe.On (b)(6) 2010, patient reported headaches, difficulty in sleeping, difficulty swallowing secretions.On (b)(6) 2010, patient reported fever.On (b)(6) 2010, patient reported incisional swelling, ache, bilateral trapezius muscles through the shoulders.On (b)(6) 2010, patient reported stiffness, neck.On (b)(6) 2016, patient reported difficulty getting up from and down on toilet seat, low chair, paresthesia (numbness) small toes of both feet; intermittent.On (b)(6) 2010, patient reported pain, lower back, severe.On (b)(6) 2010, patient reported pain, left shoulder.On (b)(6) 2011, patient reported pain, mid-thoracic, refractory to nsaids.On (b)(6) 2011, patient reported pain, left lower back.

Event Description

It was reported that it was reported that on: adverse event 1- onset (b)(6) 2010 - pain, post-operative; moderate to severe.Severity: mild.Outcome resolved on 08 jun 2010 adverse event 2- onset (b)(6) 2010 - headaches (attributed by patient to percocet).Severity: mild.Outcome resolved on (b)(6) 2010.Adverse event 3- onset (b)(6) 2010 - difficulty sleeping.Severity: mild.Outcome resolved on (b)(6) 2010.Adverse event 4- onset (b)(6) 2010 - difficulty swallowing secretions.Severity: mild.Outcome resolved on (b)(6) 2010.Adverse event 5- onset (b)(6) 2010 - fever.Severity: mild.Outcome resolved on (b)(6) 2010 adverse event 6- onset (b)(6) 2010 - incisional swelling.Severity: mild.Outcome resolved on (b)(6) 2010.Adverse event 7- onset (b)(6) 2010 - ache, bilateral trapezius muscles through the shoulders.Severity: moderate.Outcome resolved on (b)(6) 2010.Adverse event 8- onset (b)(6) 2010 - stiffness, neck.Severity: mild.Outcome resolved on (b)(6) 2010.Adverse event 9- onset (b)(6) 2016 - difficulty getting up from and down on toilet seat, low chair.Moderate.Outcome resolved on: (b)(6) 2010 adverse event 10- onset (b)(6) 2010 - paresthesia (numbness) small toes of both feet; intermittent.Severity: mild.Outcome resolved on: (b)(6) 2010 adverse event-11 - onset (b)(6) 2010 - pain, lower back, severe.Severity: moderate.Outcome resolved on: (b)(6) 2010 diagnostic test: mri, thoracic spine, diagnostic date: (b)(6) 2011, results: abnormal, multilevel degenerative disc disease, t11-12, mild dic bulge, spinal canal stenosis, c7t1 right foraminal stenosis.Adverse event 12- onset (b)(6) 2010 - pain, left shoulder (attributed by physician to possible bursitis).Moderate.Outcome resolved on (b)(6) 2011 adverse event 13- onset (b)(6) 2011 - pain, mid-thoracic, refractory to nsaids.Severity: moderate.Outcome resolved on: (b)(6) 2011 adverse event 14-onset (b)(6) 2011 - pain, left lower back.Outcome: pending/ongoing/resolved.

Manufacturer Narrative

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 USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5955415
• MDR Text Key: 54879090
• Report Number: 1030489-2016-02566
• 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: study
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/16/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/19/2016
• Initial Date FDA Received: 09/16/2016
• Supplement Dates Manufacturer Received: Not provided; 09/16/2016
• Supplement Dates FDA Received: 10/07/2016; 09/25/2017
• 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
• Patient Age: 55 YR
• Patient Weight: 81