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 Numbness (2415); Sleep Dysfunction (2517)

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 (b)(6) 2014, the patient underwent acdf surgery, in which rh-bmp2/acs was implanted.Pre-op diagnosis: degenerative disc disease type of procedure: anterior cervical discectomy and fusion (acdf)- extrapharyngeal anterolateral approach treated levels: c4-5, c5-6, c6-7 post-op, the patient had the following adverse events: ae#5: event occurrence: (b)(6) 2014 primary diagnosis: paresthesia (numbness), right hand diagnostic tests: cervical spine films, ap/lat/swimmer<(>&<)>apos;s views, diagnostic date: (b)(6) 2014, results: normal.Cervical spine plain films, ap/lat/w=swimmer<(>&<)>apos;s views, diagnostic date: (b)(6) 2015, results: normal surgical treatments: no relatedness: undetermined severity: mild; sae: no outcome: pending ae#11: event occurrence: (b)(6) 2015 primary diagnosis: progressive right hand numbness surgical treatments: no other actions: mri cervical spine planned (results not available, if obtained) relatedness: not related severity: moderate; sae: no outcome: pending ae#12: event occurrence: (b)(6) 2015 primary diagnosis: recurrent/worsening insomnia surgical treatments: no relatedness: not related severity: moderate; sae: no outcome: pending.

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: 6150498
• MDR Text Key: 61591811
• Report Number: 1030489-2016-03348
• 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: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• 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?: Yes
• 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: 60 YR
• Patient Weight: 102