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); High Blood Pressure/ Hypertension (1908); Pain (1994); Swelling (2091); Weakness (2145); Myalgia (2238); Discomfort (2330); Neck Pain (2433)

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) 2010, the patient underwent surgery with rhbmp-2.Procedure: acdf; levels: c4-c5,c5-c6,c6,c7.Pre-op diagnosis: acdf for treatment of degenerative disc disease (ddd).Onset (b)(6) 2010 hypertension, mild, transient.Onset (b)(6) 2010 incisional swelling, mild.Onset (b)(6) 2010 discomfort (nos).Onset (b)(6) 2010 dysphagia, mild (no weight loss, no airway compromise).Onset (b)(6) 2010 pain, neck ("minimal").Onset (b)(6) 2010 vocal weakness, mild.Onset (b)(6) 2010 myalgias, persistent and increasing.Onset (b)(6) 2010 the investigator noted, plan was to obtain emg <(>&<)> c-spine mri.

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

Ae#1: primary diagnosis: hypertensive episode, mild, transient.Other actions: hospitalisation; consultant characterized transient intraoperative hypertension as reactive and self-resolving.Relatedness: surgical procedure associated.Severity: mild; sae: no.Outcome: resolved, resolution date: (b)(6) 2010.Ae#2: primary diagnosis: incisional swelling, mild (post-op day #5).Other actions: nurse inspected wound, provided wound care and wound care teaching.Relatedness: surgical procedure associated.Severity: mild; sae: no.Outcome: resolved, resolution date: (b)(6) 2010.Ae#3: primary diagnosis: discomfort (nos) - post-op day #5.Other actions: current medications continued (specifically steroid wean, narcotic pain medication).Relatedness: undetermined.Severity: mild; sae: no.Outcome: resolved, resolution date: (b)(6) 2010.Ae#4: primary diagnosis: dysphagia, mild (no weight loss, no airway compromise) - post-op day #5.Other actions: current management (including steroid wean) continued.Relatedness: surgical procedure associated.Severity: mild; sae: no.Outcome: resolved, resolution date: (b)(6) 2010.Ae#5: primary diagnosis: neck pain ("minimal") - post-op day #5.Other actions: current medications continued including steroid wean and pain medication; activity restrictions reinforced.Relatedness: surgical procedure associated.Severity: mild; sae: no.Outcome: resolved, resolution date: (b)(6) 2010.Ae#6: primary diagnosis: mild vocal weakness (post-op day #5).Other actions: steroid wean continued.Relatedness: surgical procedure associated.Severity: mild; sae: no.Outcome: resolved, resolution date: (b)(6) 2010.Ae#7: primary diagnosis: myalgias, persistent and increasing.Relatedness: surgical procedure associated.Severity: mild; sae: no.Outcome: resolved, resolution date: (b)(6) 2010.Ae#8: primary diagnosis: residual subjective weakness, right upper extremity.Other actions: per note from office visit on this day, plan was to obtain emg <(>&<)> c-spine mri; however, further documentation for this patient is unavailable 24 months s/p acdf.Relatedness: not related.Severity: mild; sae: no.Outcome: unknown.

Event Description

On (b)(6) 2010 the patient underwent following surgery: type of procedure(including approach): anterior cervical discectomy and fusion (acdf)- extrapharyngeal anterolateral.

Event Description

It was reported that on ae#3: event occurrence: (b)(6) 2010 primary diagnosis: soreness after acdf surgery (no site specified or chartered) other actions: other, specify: current medications continued(specifically steroid wean, narcotic pain medication) for palliation.Relatedness: surgical procedure associated.

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: 5955204
• MDR Text Key: 54878218
• Report Number: 1030489-2016-02560
• 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,Followup
• Report Date: 11/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2016
• 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: 11/15/2016
• 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: 48 YR
• Patient Weight: 141