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 Syncope (1610); Dysphagia/ Odynophagia (1815); Headache (1880); Pain (1994); Swelling (2091); Urinary Tract Infection (2120); Blurred Vision (2137); Weakness (2145); Tingling (2171); Numbness (2415); Neck Pain (2433); Sleep Dysfunction (2517); Weight Changes (2607)

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) 2009 patient was implanted with rhbmp-2.Initial diagnosis: acdf for treatment of degenerative disc disease (ddd).Procedure: anterior cervical discectomy and fusion (acdf)- extrapharyngeal anterolateral approach levels: c4-c5, c5-c6, c6-c7 on (b)(6) 2009 the patient reported numbness, tips of right thumb, index and middle fingers.On (b)(6) 2009 the patient reported incisional site swelling.On (b)(6) 2009 the patient reported urinary tract infection with fever on (b)(6) 2009 the patient reported syncopal episode on (b)(6) 2009 the patient reported difficulty swallowing (patient feels like food is getting "stuck" in his throat).On (b)(6) 2009 the patient reported interval weight loss and difficulty in swallowing.On (b)(6) 2009 the patient reported subjective weakness, generalized.On (b)(6) 2009 the patient reported insomnia.On (b)(6) 2009 the patient reported right shoulder pain (tightness).On (b)(6) 2009 the patient reported right shoulder pain (tightness).On (b)(6) 2010 the patient reported neck pain (aching; attributed by clinician to strain).On (b)(6) 2010 the patient reported tingling, both arms.On (b)(6) 2011 the patient reported paresthesia, scalp (prickling sensation) attributed to varicella zoster/shingles.On (b)(6) 2011 the patient reported headaches.On (b)(6) 2011 the patient reported episodic blurred vision.

Manufacturer Narrative

Additional information: age/date of birth, describe event or problem.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.

Event Description

It was reported that the patient underwent surgery on (b)(6) 2009 ae#1 event occurrence; (b)(6) 2009 primary diagnosis: numbness, tips of right thumb, index and middle fingers other actions: no other actions severity: mild outcome: resolved, resolution date: (b)(6) 2010 ae#10 event occurrence; (b)(6) 2009 primary diagnosis: right shoulder pain (tightness) severity: moderate outcome: resolved, resolution date: (b)(6) 2009 ae#11 event occurrence; (b)(6) 2010 primary diagnosis: neck pain severity: mild outcome: pending ae#12 event occurrence; (b)(6) 2011 primary diagnosis: parasthesia, scalp severity: mild outcome: pending ae#13 event occurrence; (b)(6) 2010 primary diagnosis: tingling, both arms diagnostic test: mri, cervical spine.Diagnostic date: (b)(6) 2010, results: abnormal, c3-4, disc osteophyte complex eccentric to the left minimal effacement of ventral subarachnoid spaces; no cord compression.Other actions: no other actions severity: mild outcome: pending ae#15 event occurrence; (b)(6) 2011 primary diagnosis: episodic blurred vision severity: mild outcome: unknown ae#2 event occurrence; (b)(6) 2009 primary diagnosis: incisional site swelling relatedness: surgical procedure associated severity: mild outcome: resolved, resolution date: (b)(6) 2009 ae#3 event occurrence; (b)(6) 2009 primary diagnosis: urinary tract infection severity: mild outcome: resolved, resolution date: (b)(6) 2009 ae#4 event occurrence; (b)(6) 2009 primary diagnosis: syncopal episode severity: moderate outcome: resolved, resolution date: (b)(6) 2009 ae#5 event occurrence; (b)(6) 2009 primary diagnosis: difficulty in swallowing relatedness: surgical procedure related severity: mild outcome: resolved, resolution date: (b)(6) 2009 ae#6 event occurrence; (b)(6) 2009 primary diagnosis: interval weight loss relatedness: surgical procedure associated severity: moderate outcome: resolved, resolution date: (b)(6) 2010 ae#7 event occurrence; (b)(6) 2009 primary diagnosis: subjective weakness severity: moderate outcome: resolved, resolution date: (b)(6) 2009 ae#8 event occurrence; (b)(6) 2009 primary diagnosis: insomnia severity: moderate outcome: resolved, resolution date: (b)(6) 2009 ae#9 event occurrence; (b)(6) 2009 primary diagnosis: swelling, neck pain severity: mild outcome: resolved, resolution date: (b)(6) 2009.

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: 5920399
• MDR Text Key: 53661909
• Report Number: 1030489-2016-02441
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• 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

• Date FDA Received: 09/01/2016
• 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
• Date Manufacturer Received: 09/16/2016
• 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: 58 YR
• Patient Weight: 95