MAUDE Adverse Event Report: NOVABONE PRODUCTS, LLC NOVABONE DENTAL PUTTY; BONE GRAFTING MATERIAL SYNTHETIC

Model Number	NA3640
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot numbers were not provided by the dentist.Retain samples from products shipped between sept 2015 - april 2016 were pulled.Device history records were reviewed for each lot.Bioactivity testing was performed on the reatin samples, all samples passed bioactivity testing.Complaint could not be verified.Device(s) not returned by the user.
Event or Problem Description
Approximately 6 failures of dental putty to remodel in patients with abscessed teeth.The "mushy material" (believed to be novabone putty) was removed and the area re-grafted by the surgeon.No final outcome is know at this point.

• Brand Name: NOVABONE DENTAL PUTTY
• Common Device Name: BONE GRAFTING MATERIAL SYNTHETIC
• Manufacturer (Section D): NOVABONE PRODUCTS, LLC; 13510 nw us hwy 441; alachua FL 32615
• MDR Report Key: 6254566
• Report Number: 3003768919-2016-00001
• Device Sequence Number: 13692032
• Product Code: LYC
• UDI-Device Identifier: 00813909010755
• UDI-Public: 00813909010755
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K100671
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 12/19/2016

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
• Operator of Device: Dentist
• Device Model Number: NA3640
• Device Catalogue Number: NA3640
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/15/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2016
• Initial Report FDA Received Date: 01/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other