T8 2-0 Vio Br Pga 36"/90cm G354NRecalls & reported problems
Surgical Specialties México, S. de R.L. de C.V. · T8 2-0 Vio Br Pga 36"/90cm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00848782014538), received between Feb 20, 2023 and Feb 20, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break1
Patient problems
- Bacterial Infection1
- Impaired Healing1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 20, 2023Break
SUTURE BROKEN WHEN WOUND WAS HEALING. ON (B)(6), 2023, THE NURSE FOUND THAT THE PATIENT''S WOUND SUTURES WERE BROKEN, RESULTING IN POOR WOUND HEALING, SO SHE EXPLAINED TO THE PATIENT THAT SHE WAS CONSIDERING THE QUALITY OF THE PRODUCT THAT CAUSED THE SUTURES TO BREAK AND REPORTED IT AS AN ADVERSE EVENT. A SMALL AMOUNT OF YEAST GROWTH BACTERIA PRESENT. COMBINED MEDICAL TREATMENT POST-OPERATIVE DUE TO POOR WOUND HEALING OF THE LATERAL INCISION. PATIENT HEALTH IMPROVING.
Patient problems: Bacterial Infection; Impaired Healing
MAUDE report 16403981 ↗
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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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