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); Pain (1994); Burning Sensation (2146); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

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 levels implanted: c5-c6, c6-c7.On (b)(6) 2009 the patient underwent anterior cervical discectomy and fusion (acdf)-extrapharyngeal anterolateral approach levels implanted: c5-c6, c6-c7.Initial diagnosis: acdf for treatment of degenerative disc disease (ddd).Onset (b)(6) 2009 the patient reported pain at surgical site.Onset (b)(6) 2009 the patient reported paresthesia (numbness), bilateral upper extremities and both feet (attributed by patient to overexertion.Onset (b)(6) 2010 history of dysphagia post-operatively (nos);self resolved.Onset 2/02/2010- paresthesia (numbness) bilaterally in cervical 6-7 nerve root distribution.

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.

Event Description

Adverse event 1-onset (b)(6) 2009- pain at surgical site relatedness: surgical procedure associated.Severity: mild; sae: no.Outcome: resolved, resolution date: (b)(6) 2009.Adverse event 2-onset (b)(6) 2009- paresthesia (numbness), bilateral upper extremities and both feet other relatedness: not related.Severity: mild; sae: no.Outcome: resolved, resolution date: (b)(6) 2010 adverse event 3-onset (b)(6) 2010- history of dysphagia post-operatively relatedness: surgical procedure associated.Severity: mild; sae: no.Outcome: resolved, resolution date: (b)(6) 2010.Adverse event 4: onset (b)(6) 2010- paresthesia (numbness) bilaterally in cervical 6-7 nerve root distribution relatedness: not related.Severity: mild; sae: no.Outcome: resolved, resolution date: (b)(6) 2010.

Event Description

It was reported that ae#5: event occurrence date: (b)(6) 2009 primary diagnosis: paresthesias, both feet outcome: resolved, resolution date: (b)(6) 2010.

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: 5951789
• MDR Text Key: 54748533
• Report Number: 1030489-2016-02547
• 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,Followup
• Report Date: 11/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2016
• 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: 11/17/2016
• 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: 54 YR
• Patient Weight: 84