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 Apnea (1720); Pain (1994); Swelling (2091); Burning Sensation (2146); Tingling (2171); Numbness (2415); 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, rhbmp-2 along with two interbody spacer were implanted.Procedure: 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) adverse event 1-onset (b)(6) 2010 pain, mild to moderate.Adverse event 2- onset (b)(6) 2010 apnea.Adverse event 3-onset (b)(6) 2010 incisional swelling.Adverse event 4-onset (b)(6) 2010 pain neck and arm.Adverse event 5- onset (b)(6) 2010 paresthesias (intermittent numbness, tingling, burning), right forearm.Adverse event 6- onset (b)(6) 2010 pain, spasmodic, right posterior trapezius.Adverse event 7- onset (b)(6) 2010 twinge in neck, that evolved into subsequent spasmodic right posterior trapezius pain.Adverse event 8-onset (b)(6) 2011 stiffness, left shoulder.

Event Description

It was reported that on adverse event# 2.Onset date: (b)(6) 2010, primary diagnosis: apneic episode in recovery room status post acdf under general anasthesia.Other actions: other, specify: tactile stimulation (sterile rub) produced minimal results; narcan adminstered w/ immediate reversal of bradypnea, oxygen saturations.Outcome: resolved.Resolution date: (b)(6) 2010 update received on (b)(6) 2016: adverse event# 3 onset date: (b)(6) 2010 other actions: nurse provided wound care teaching relatedness: surgical procedure associated outcome: resolved, resolution date: (b)(6) 2010 adverse event# 4 onset date: (b)(6) 2010 primary diagnosis: post-operative pain after acdf surgery.Severity: mild outcome: resolved, resolution date: (b)(6) 2010 adverse event# 5 onset date: (b)(6) 2010 primary diagnosis: paresthesias, right forearm.Severity: mild outcome: resolved, resolution date: (b)(6) 2010 adverse event# 6 onset date: (b)(6) 2010 primary diagnosis: muscle spasms, right posterior trapezius diagnostic test: diagnostic test: plain films, c-spine, ap and lat views, diagnostic date: (b)(6) 2010, results: normal diagnostic test: plain films, c-spine, ap and lat view, diagnostic date: (b)(6) 2010, results: normal severity: mild outcome: resolved, resolution date: (b)(6) 2010 adverse event# 7 onset date: (b)(6) 2010 primary diagnosis: "twinge" in neck diagnostic test: plain films, c-spine, ap and lat views, diagnostic date: (b)(6) 2010, results: normal diagnostic test: plain films, c-spine, ap and lat view, diagnostic date: (b)(6) 2010, results: normal severity: mild outcome: resolved, resolution date: (b)(6) 2010.

Event Description

It was reported that ae#1: primary diagnosis: neck pain after acdf surgery (onset date: (b)(6) 2010) surgical treatments: no other actions: bed rest; nonpharmacologic comfort measures provided by nursing staff and family relatedness: surgical procedure associated severity: mild; sae: no outcome: resolved, resolution date: (b)(6) 2010.Ae# 4 exam date: (b)(6) 2016 event occurence: (b)(6) 2010 primary diagnosis: pain, neck agter acdf surgery.Other actions: assessed by nurse in clinic w/no change in current management(including pain and anti- inflammatory medications); follow up appointment scheduled.Relatedness: surgical procedure associated.Sae: no.Outcome: resolved: resolution date: (b)(6) 2010 ae# 9 exam date: (b)(6) 2016 event occurence: (b)(6) 2010 primary diagnosis: pain, arm (nos), after acdf surgery.Other actions: evaluated in clinic by nurse w/no changes made in current management(including analgesic and anti-inflammatory medications); next post-op visit severity: mild resolved: resolution date: (b)(6) 2010.

Event Description

It was reported that on ae# 4 exam date: (b)(6) 2016 event occurence: (b)(6) 2010 primary diagnosis: pain, neck after acdf surgery.Other actions: assessed by nurse in clinic w/no change in current management (including pain and anti- inflammatory medications); follow up appointment scheduled.Relatedness: surgical procedure associated.Sae: no.Outcome: resolved: resolution date: (b)(6) 2010 ae# 9 exam date: (b)(6) 2016 event occurence: (b)(6) 2010 primary diagnosis: pain, arm (nos), after acdf surgery.Other actions: evaluated in clinic by nurse w/no changes made in current management (including analgesic and anti-inflammatory medications); next post-op visit severity: mild resolved: resolution date: (b)(6) 2010 update received on 17 nov 2016: ae#6 relatedness: not related sae: no ae#9 relatedness: surgical procedure associated sae: no.

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: 5955218
• MDR Text Key: 54878426
• Report Number: 1030489-2016-02562
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2010
• Device Catalogue Number: 7510050
• Device Lot Number: M110910AAE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/22/2016
• Initial Date FDA Received: 09/16/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 11/15/2016
• Supplement Dates FDA Received: 10/17/2016; 11/16/2016; 12/07/2016; 09/25/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/05/2010
• 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: 52 YR
• Patient Weight: 67