MAUDE Adverse Event Report: NOVABONE PRODUCTS, LLC PERIOGLAS; SYNTHETIC BONE GRAFT

Model Number	NA0260
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling (2091)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history records for lot 1709b2 were reviewed.No nonconformances or deviations were associated with the lot.Manufacturing, sterilization, and distribution were all conducted according to specification.This device is terminally sterilized using gamma irradiation.No product was returned for review.A review of complaints from indicated no other issues with lot 1709b2.No complaints of infection, inflammation, or allergic reactions have been received for perioglas (dental particulate bone graft) devices.The likelihood that the novabone device contributed to this event is low when compared to the procedure risks itself.
Event or Problem Description
Report received that the last 4 patients who had product code: na0260 implanted of lot: 1709b2 required graft removal due to "allergic reaction", swelling, pain.

• Brand Name: PERIOGLAS
• Common Device Name: SYNTHETIC BONE GRAFT
• Manufacturer (Section D): NOVABONE PRODUCTS, LLC; 13510 nw us 441; alachua FL 32615
• MDR Report Key: 8366654
• Report Number: 3003768919-2019-00001
• Device Sequence Number: 16476852
• Product Code: LYC
• UDI-Device Identifier: 00813909010625
• UDI-Public: 00813909010625
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K053387
• 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): 02/19/2019

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: Health Professional
• Device Expiration Date: 04/15/2023
• Device Model Number: NA0260
• Device Catalogue Number: NA0260
• Device Lot Number: 1709B2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 02/25/2019
• 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