Cytoplast™ PTFE Suture CS0618PREMRecalls & reported problems
Osteogenics Biomedical Inc · Non-resorbable Polytetrafluoroethylene (PTFE) Monofilament Suture, USP 4-0, Precision Reverse Cutting 13 mm 3/8 Circle Needle · Class 2 · Implant
Data updated Oct 13, 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 D765CS0618PREM0), received between Mar 12, 2021 and Mar 12, 2021 — classified as 2 injuries.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Swelling/ Edema2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
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.
Patient problems: Swelling/ Edema
MAUDE report 11475156 ↗InjuryMar 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
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 HEALED UPON SUTURE REMOVAL AND THEREFORE THERE WAS NO SERIOUS OUTCOME.
Patient problems: Swelling/ Edema
MAUDE report 11475115 ↗
Other Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene devices
- CYTOSURG T8665CRiverpoint Medical, LLC · Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene3 reports
- MONOTEX T8695CRiverpoint Medical, LLC · Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene2 reports
- MONOTEX T8001CRiverpoint Medical, LLC · Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene1 report
- CYTOSURG T8682CRiverpoint Medical, LLC · Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene1 report
- Maxima 1127253Henry Schein, Inc. · SUTURE, SURGICAL, NONABSORBABLE, EXPANDED, POLYTETRAFLOUROETHYLENE1 report
- Maxima 1127260Henry Schein, Inc. · SUTURE, SURGICAL, NONABSORBABLE, EXPANDED, POLYTETRAFLOUROETHYLENE1 report
- Maxima 1127256Henry Schein, Inc. · SUTURE, SURGICAL, NONABSORBABLE, EXPANDED, POLYTETRAFLOUROETHYLENE1 report
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page