2de14 2-0 Undyd Monoderm 30x30 YA-1024Q-0Recalls & reported problems
Surgical Specialties México, S. de R.L. de C.V. · 2de14 2-0 Undyd Monoderm 30x30 · 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 00848782021970), received between Apr 23, 2021 and Aug 14, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (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.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation1
- Packaging Problem1
Patient problems
- Foreign Body In Patient1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 14, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED ON 23 JULY 2025 THAT INTRA-OPERATIVELY A NEEDLE BROKE AND PIECES WERE LEFT IN-SITU. NO ADDITIONAL INFORMATION WAS RECEIVED.
Patient problems: Foreign Body In Patient
MAUDE report 22811264 ↗MalfunctionApr 23, 2021Packaging Problem
DURING A BREAST REDUCTION PROCEDURE, THE SCRUB TECH NOTICED THAT A QUILL MONODERM SUTURE YA-1024Q-0 SHOULD BE A DOUBLE ARM SUTURE. THE PACKAGE HAD AN INCORRECT PRODUCT INSIDE.
Patient problems: Insufficient Information
MAUDE report 11715545 ↗
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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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