2de14 2-0 Undyd Monoderm 14x14 YA-1015Q-0Recalls & reported problems
Surgical Specialties México, S. de R.L. de C.V. · 2de14 2-0 Undyd Monoderm 14x14 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00848782021765), received between Oct 31, 2024 and Oct 31, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component2
- Separation Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 31, 2024Detachment of Device or Device Component; Separation Problem; Detachment of Device or Device Component; Separation Problem
IT WAS REPORTED ON (B)(6) 2024 THAT DURING A SURGICAL PROCEDURE THE NEEDLE DETACHED FROM THE THREAD CAUSING A DELAY GREATER THAN 30 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20578648 ↗MalfunctionOct 31, 2024Detachment of Device or Device Component; Separation Problem; Detachment of Device or Device Component; Separation Problem
IT WAS REPORTED ON (B)(6) 2024 THAT DURING A SURGICAL PROCEDURE THE NEEDLE DETACHED FROM THE THREAD CAUSING A DELAY GREATER THAN 30 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20578548 ↗
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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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