MAUDE Adverse Event Report: OSTEOGENICS BIOMEDICAL, INC. OSSEOGUARD TR250 PTFE MEMBRANE; TITANIUM-REINFORCED PTFE MEMBRANE

Model Number	TR250RAK-1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, complete information is not available in spite of efforts to obtain further information from the clinician.Guided bone regeneration (gbr) procedures are highly technique sensitive, and infection is a known complication.There are published protocols outlining steps to take in the case of infection (1).The unit has not been returned to date, so the device has not been inspected.The lot history was reviewed and the product was verified to have been manufactured correctly and sterilized via a validated sterilization cycle, and no discrepancies were found.Ptfe is a bioinert material.There are many clinical factors that could lead to this event, and based on the review of the lot history and complaint trending, we do not believe this was device related at this time.We are submitting this report to be conservative and in an abundance of caution.This device was sold and used in france.1.Vroom m, grundemann l, gallo p.Clinical classification of healing complications and management in guided bone regeneration procedures with a nonresorbable d-ptfe membrane.International journal of periodontics & restorative dentistry 2022;42:419-427.
Event or Problem Description
Doctor reported infection at the graft site and removal of the membrane and bio-bone.

• Brand Name: OSSEOGUARD TR250 PTFE MEMBRANE
• Common Device Name: TITANIUM-REINFORCED PTFE MEMBRANE
• Manufacturer (Section D): OSTEOGENICS BIOMEDICAL, INC.; 4620 71st st. bldg. 78; lubbock TX 79424
• Manufacturer (Section G): OSTEOGENICS BIOMEDICAL, INC.; 4620 71st st. bldg. 75; lubbock TX 79424
• Manufacturer Contact: shane shuttlesworth ; 4620 71st st. bldg. 78; lubbock, TX 79424 ; 8067961923
• MDR Report Key: 15069910
• Report Number: 1650372-2022-00001
• Device Sequence Number: 14877764
• Product Code: LYC
• UDI-Device Identifier: 00844868042020
• UDI-Public: 00844868042020
• Combination Product (Y/N): N
• PMA/510(K) Number: K972278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 07/20/2022

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: 03/28/2025
• Device Model Number: TR250RAK-1
• Device Lot Number: V2J006A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2022
• Initial Report FDA Received Date: 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown