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 Erythema (1840); Pain (1994); Swelling (2091); Tingling (2171); Arthralgia (2355); 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 the patient underwent anterior cervical discectomy and fusion (acdf) through extrapharyngeal ant erolateral approach on level c5-6, c6-7 with rhbmp-2/acs.Initial diagnosis: acdf for treatment of degenerative disc disease (ddd) on (b)(6) 2010, patient reported pain, moderate to severe (in recovery room after surgery).On (b)(6) 2010, patient reported incisional swelling, transient diffuse skin erythmea, paresthesias (numbness, tingling) left index, middle, ring fingers.On (b)(6) 2010, patient reported joint pain, neck <(>&<)> hands.On (b)(6) 2010, patient reported recurrent paresthesias, left arm and fingers.

Event Description

It was reported that on ae#1: onset (b)(6) 2010 primary diagnosis: pain (nos), in recover room s/p acdf.No surgical treatments needed.Other actions: non-pharmacologic comfort measures provided by nursing staff, family.Relatedness: surgical procedure associated.Severity: mild; sae: no; outcome: resolved, resolution date: (b)(6) 2010.Ae#4: onset (b)(6) 2010 primary diagnosis: "paresthesias (numbness, tingling) left index, middle, ring fingers).Relatedness: not related.Severity: mild; sae: no; outcome: resolved, resolution date: (b)(6) 2010.Ae#5: onset (b)(6) 2010 primary diagnosis: joint pain, neck and hands relatedness: not related.Severity: moderate; sae: no; outcome: resolved, resolution date: (b)(6) 2010.Ae#7: event occurrence: (b)(6) -2010 primary: diagnosis: arthralgias, both hands.Relatedness:not related severity: mild; sae: no; outcome: resolved, resolution date: (b)(6) 2010.

Event Description

It was reported that ae#6: relatedness: not related.Severity: mild.Sae: no.Outcome: unknown.

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: 5955217
• MDR Text Key: 54879017
• Report Number: 1030489-2016-02561
• 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: 10/24/2016

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: 11/30/2010
• Device Catalogue Number: 7510050
• Device Lot Number: M110906AAF
• 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; Not provided; 10/24/2016
• Supplement Dates FDA Received: 10/17/2016; 11/16/2016; 09/25/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/20/2009
• 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: 49 YR
• Patient Weight: 90