Dsm13 4-0 Und Br Pga 18"/45cm G494NRecalls & reported problems
Surgical Specialties México, S. de R.L. de C.V. · Dsm13 4-0 Und Br Pga 18"/45cm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00848782015023), received between May 9, 2025 and Oct 17, 2025 — classified as 9 injuries.
The most frequently reported specific device problem is “Break” (6 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
- Break6
- Adverse Event Without Identified Device or Use Problem2
- Detachment of Device or Device Component1
Patient problems
- Wound Dehiscence8
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED ON (B)(6) 2025 THAT A PATIENT EXPERIENCED WOUND DEHISCENCE POST-OPERATIVELY. THE WOUND WAS RE-SUTURED AND NO ADDITIONAL INJURY WAS REPORTED.
Patient problems: Wound Dehiscence
MAUDE report 23328878 ↗InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED ON (B)(6) 2025 THAT A PATIENT EXPERIENCED WOUND DEHISCENCE POST-OPERATIVELY. THE WOUND WAS RE-SUTURED AND NO ADDITIONAL INJURY WAS REPORTED.
Patient problems: Wound Dehiscence
MAUDE report 23318977 ↗InjurySep 11, 2025Break; Break
IT WAS REPORTED ON (B)(6) 2025 THAT A PATIENT EXPERIENCED WOUND DEHISCENCE. NO ADDITIONAL INFORMATION WAS RECEIVED.
Patient problems: Wound Dehiscence
MAUDE report 23031548 ↗InjurySep 11, 2025Break; Break
IT WAS REPORTED ON (B)(6) 2025 THAT A PATIENT EXPERIENCED WOUND DEHISCENCE. NO ADDITIONAL INFORMATION WAS RECEIVED.
Patient problems: Wound Dehiscence
MAUDE report 23031390 ↗InjurySep 11, 2025Break; Break
IT WAS REPORTED ON (B)(6) 2025 THAT A PATIENT EXPERIENCED WOUND DEHISCENCE. NO ADDITIONAL INFORMATION WAS RECEIVED.
Patient problems: Wound Dehiscence
MAUDE report 23031156 ↗InjurySep 11, 2025Break; Break
IT WAS REPORTED ON (B)(6) 2025 THAT A PATIENT EXPERIENCED WOUND DEHISCENCE. NO ADDITIONAL INFORMATION WAS RECEIVED.
Patient problems: Wound Dehiscence
MAUDE report 23030940 ↗InjurySep 9, 2025Break; Break
IT WAS REPORTED ON (B)(6) 2025 THAT A PATIENT EXPERIENCED WOUND DEHISCENCE. NO ADDITIONAL INFORMATION WAS RECEIVED.
Patient problems: Wound Dehiscence
MAUDE report 23011712 ↗InjurySep 3, 2025Break; Break
IT WAS REPORTED ON (B)(6) 2025 THAT A PATIENT EXPERIENCED WOUND DEHISCENCE. NO ADDITIONAL INFORMATION WAS RECEIVED.
Patient problems: Wound Dehiscence
MAUDE report 22955582 ↗InjuryMay 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED ON (B)(6) 2025 THAT A NEEDLE BROKE INTRAOPERATIVELY. NO PATIENT INJURY OCCURRED; HOWEVER, INTERVENTION WAS REQUIRED TO REMOVE THE NEEDLE FROM THE PATIENT. NO ADDITIONAL INTERVENTION REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21992339 ↗
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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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