MAUDE Adverse Event Report: OSTEOGENICS BIOMEDICAL, INC. CYTOPLAST PTFE SUTURE

Model Number	CS0618PREM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The units were not returned, so they could not be 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 and this is the first complaint received by osteogenics concerning tissue irritation/swelling.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.
Event or Problem Description
The clinician stated that the tissue around the ptfe suture became swollen and therefore had a higher tension on the flap.The suture had to be removed early and upon removal the irritation disappeared.The patient was also prescribed antibiotics because the tissue looked 'necrotic'.The patient healed upon suture removal and therefore there was no serious outcome.

• Brand Name: CYTOPLAST PTFE SUTURE
• Common Device Name: PTFE SUTURE
• Manufacturer (Section D): OSTEOGENICS BIOMEDICAL, INC.; 4620 71st st. bldg. 78; lubbock TX 79424
• MDR Report Key: 11475156
• Report Number: 1650372-2021-00003
• Device Sequence Number: 4625064
• Product Code: NBY
• UDI-Device Identifier: D765CS0618PREM0
• UDI-Public: +D765CS0618PREM0/$$3240528RC06435A
• Combination Product (Y/N): N
• PMA/510(K) Number: K072076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 03/10/2021

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: 05/28/2024
• Device Model Number: CS0618PREM
• Device Lot Number: RC06435A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 03/12/2021
• 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: Required Intervention