MAUDE Adverse Event Report: SALVIN DENTAL SPECIALTIES SALVIN CYTOSURG; NON-RESORBABLE PTFE MEMBRANE 12X24

Model Number CYTOSURG-12X24

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Local Reaction (2035)

Event Date 12/18/2020

Event Type  Injury  

Manufacturer Narrative

It was confirmed that, per instructions for use, the cytosurg membrane was removed at 3 weeks.

Event Description

The doctor is concerned patient may have allergy to the cytosurg membrane since there is pain and redness in the area.The doctor opened up the site to scrape out a couple granular pieces of bone.No remnants of cytosurg were found.

• Brand Name: SALVIN CYTOSURG
• Type of Device: NON-RESORBABLE PTFE MEMBRANE 12X24
• Manufacturer (Section D): SALVIN DENTAL SPECIALTIES; 3450 latrobe drive; charlotte NC 28211
• MDR Report Key: 12205416
• MDR Text Key: 262872217
• Report Number: 1066741-2021-00001
• Device Sequence Number: 1
• Product Code: NPK
• Combination Product (y/n): N
• PMA/PMN Number: K160493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 01/11/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2023
• Device Model Number: CYTOSURG-12X24
• Device Catalogue Number: CYTOSURG-12X24
• Device Lot Number: 34316
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/11/2021
• Initial Date FDA Received: 07/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2019
• 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): Required Intervention