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 Pain (1994); Weakness (2145); Inadequate Pain Relief (2388); 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) 2011, patient underwent anterior cervical discectomy and fusion where rhbmp-2/acs was implanted in the patient.Pre-op diagnosis: acdf for treatment of degenerative disc disease (ddd); procedure: anterior cervical discectomy and fusion (acdf)- extrapharyngeal anterolateral approach; levels: c5-c6, c6-c7 post-operative, patient reported on (b)(6) 2013, patient reported recurrent neck pain.Diagnostic test: ap and amp; lateral cervical spine radiographs, diagnostic date: (b)(6) 2013, results: normal.On (b)(6) 2013, patient reported dysesthesias in both upper extremities with weakness of both grips (right>left).Diagnostic test: ap and amp; lateral cervical spine radiographs,diagnostic date: (b)(6) 2013, results: normal.On (b)(6) 2012, patient reported burning sensation, center of right palm, associated with incision status post right carpal tunnel release.

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.

• 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: 6010151
• MDR Text Key: 56790932
• Report Number: 1030489-2016-02787
• 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
• Report Date: 09/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2012
• Device Catalogue Number: 7510050
• Device Lot Number: M111102AAK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/13/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/19/2011
• 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: 53 YR
• Patient Weight: 112