Darby Dental Supply, LLC 734S-DARRecalls & reported problems
Darby Dental Supply, LLC · SUTURE SILK 1/2 NJ-1 4/0 18" DARBY · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889813003183), received between May 10, 2024 and May 10, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Material Integrity Problem2
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 10, 2024Material Integrity Problem; Material Integrity Problem
A COMPLAINT WAS RECEIVED CONCERNING PART NUMBER (B)(4). , LOT 230203-64, SIZE 4/0 SILK SWAGE SUTURE. ACCORDING TO THE REPORT, THE SUTURE DETACHED FROM THE NEEDLE DURING SURGERY. NO INJURIES OR DELAY IN THE SURGICAL PROCEDURE WAS REPORTED BY THE CLINIC.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 19287043 ↗MalfunctionMay 10, 2024Material Integrity Problem; Material Integrity Problem
A COMPLAINT WAS RECEIVED CONCERNING PART NUMBER 734S-DAR. LOT 221101-56, SIZE 4/0 SILK SWAGE SUTURE. ACCORDING TO THE REPORT, THE SUTURE DETACHED FROM THE NEEDLE DURING SURGERY. NO INJURIES OR DELAY IN THE SURGICAL PROCEDURE WAS REPORTED BY THE CLINIC.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 19287028 ↗
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- Sofsilk S-1768KCovidien LP · SUTURE, NONABSORBABLE, SILK2 recalls5 reports
- Sofsilk S-304Covidien LP · SUTURE, NONABSORBABLE, SILK2 recalls2 reports
- Sofsilk S-316Covidien LP · SUTURE, NONABSORBABLE, SILK2 recalls2 reports
- Sofsilk S-187Covidien LP · SUTURE, NONABSORBABLE, SILK2 recalls1 report
- Sofsilk S-605Covidien LP · SUTURE, NONABSORBABLE, SILK2 recalls1 report
- Sofsilk S-246Covidien LP · SUTURE, NONABSORBABLE, SILK2 recalls0 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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