T14 3-0 Vio Br Pga 27"/70cm 311BRecalls & reported problems
Surgical Specialties México, S. de R.L. de C.V. · T14 3-0 Vio Br Pga 27"/70cm · 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 00848782008711), received between Jul 1, 2024 and Jul 2, 2024 — classified as 2 malfunctions.
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.
MalfunctionJul 2, 2024Detachment of Device or Device Component; Separation Problem; Detachment of Device or Device Component; Separation Problem
WHEN THE QUILL WAS REMOVED FROM THE BODY AFTER SUTURING, THE NEEDLE CAUGHT ON THE TROCAR, THE NEEDLE AND SUTURE WERE DETACHED, AND THE NEEDLE FELL INTO THE BODY. IT WAS REMOVED IMMEDIATELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19656320 ↗MalfunctionJul 1, 2024Detachment of Device or Device Component; Separation Problem; Detachment of Device or Device Component; Separation Problem
PER THE REPORTER THE NEEDLE TIP HAD NOT COME OUT OF THE TISSUE, SO IT WAS GRABBED AND REINSERTED FURTHER, THEN DETACHED FROM THE SUTURE WHEN IT WAS TIGHTENED. THE NEEDLE DROPPED INTO THE BODY BUT WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19651081 ↗
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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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