Premium UNIFY PGA Sutures PSGU-418R13Recalls & reported problems
Applied Dental, Inc. · Premium UNIFY PGA Sutures, Sm 4-0, 13mm 3/8 Circle Rev Cut, 18" Undyed. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00814639021547), received between Jul 26, 2022 and Oct 4, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Patient Device Interaction Problem1
Patient problems
- Inflammation1
- Skin Discoloration1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE ITEM USER CONTACT OUR US AGENT AND REPORT THAT THE ITEM SEEMS TO CAUSE A INFLAMMATORY REACTION LIKE ERYTHEMA ON THE PATIENT.
Patient problems: Skin Discoloration
MAUDE report 15534761 ↗InjuryJul 26, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
DOCTOR EMAILED US ABOUT CONCERN OF THE QUALITY OF THE PREMIUM PGA SUTURES. THEY SEEM TO CONSISTENTLY CAUSE A VERY SIGNIFICANT INFLAMMATORY REACTION ON HER PATIENTS.
Patient problems: Inflammation
MAUDE report 15108174 ↗
Other Suture, Absorbable, Synthetic, Polyglycolic Acid devices
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- V-Loc 180 VLOCL0316Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall376 reports
- Coated VICRYL VCP345HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 death405 reports
- V-Loc 180 VLOCL0604Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall328 reports
- V-Loc 180 VLOCA008LCovidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall294 reports
- V-Loc 180 VLOCL0326Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID330 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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