2de12 3-0 Undyd Monoderm 30x30 YA-1021QRecalls & reported problems
Surgical Specialties México, S. de R.L. de C.V. · 2de12 3-0 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 00848782021871), received between Dec 3, 2025 and May 21, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (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 Fragmentation2
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.
MalfunctionMay 21, 2026Material Fragmentation
IT WAS REPORTED ON (B)(6) 2026 THAT, DURING USE, THE NEEDLE BROKE, FELL INTO THE PATIENT, AND WAS SUCCESSFULLY RETRIEVED. NO PATIENT INJURY OR ADDITIONAL MEDICAL INTERVENTION REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25246090 ↗MalfunctionDec 3, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED ON (B)(6) 2025 THAT A NEEDLE BROKE INTRAOPERATIVELY. NO PATIENT INJURY OCCURRED; HOWEVER, INTERVENTION WAS REQUIRED TO REMOVE IT FROM THE PATIENT. NO ADDITIONAL INTERVENTION REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23708673 ↗
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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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