Dsm19 3-0 Und Mnd 27"/70cm Y427NRecalls & reported problems
Surgical Specialties México, S. de R.L. de C.V. · Dsm19 3-0 Und Mnd 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00848782021246), received between May 11, 2023 and Dec 6, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (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
- Adverse Event Without Identified Device or Use Problem1
- Patient Device Interaction Problem1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Wound Dehiscence1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 6, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
ON 15 NOV 2024, IT WAS REPORTED THAT THE SURGEON HAD BEEN INFORMED OF APPROXIMATELY 10 CASES OF ERYTHEMA AROUND THE SURGICAL SITE SINCE ON (B)(6) 2024. ALL AFFECTED PATIENTS WERE TREATED WITH ANTIBIOTICS, AND NO SIGNS OF INFECTION WERE OBSERVED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 20867676 ↗InjuryMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REPORTED BY THE ORTHO SURGEON DR. (B)(6), (B)(6), SUTURES WERE DULL, BREAKING, AND CAUSING TRAUMA TO THE SKIN-DEHISCENCE OF WOUND DUE TO SUTURE BREAKING ON PATIENT, RESULTING IN A RETURN BACK TO CORE PCART.
Patient problems: Wound Dehiscence
MAUDE report 16910584 ↗
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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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