Dsm13 5-0 Und Br Pga 18"/45cm G493NRecalls & reported problems
Surgical Specialties México, S. de R.L. de C.V. · Dsm13 5-0 Und Br Pga 18"/45cm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00848782014996), received between Dec 6, 2024 and Dec 13, 2024 — classified as 8 injuries.
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 Problem8
Patient problems
- Nodule8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryDec 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2024, IT WAS REPORTED THAT GRANULOMAS OCCURRED A SECOND TIME AFTER MEDICAL INTERVENTION WAS NEEDED DUE TO INITIAL GRANULOMA FORMATION THAT RESULTED IN PROLONGED HEALING AND SCARRING.
Patient problems: Nodule
MAUDE report 20929648 ↗InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2024, THE REPORTER NOTED THE FORMATION OF GRANULOMAS POST-OPERATIVELY. SUBSEQUENTLY, ON (B)(6) 2024, IT WAS REPORTED THAT MEDICAL INTERVENTION WAS REQUIRED TO REMOVE NON-DEGRADED SUTURES, LEADING TO PROLONGED WOUND HEALING AND SCARRING.
Patient problems: Nodule
MAUDE report 20868782 ↗InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2024, THE REPORTER NOTED THE FORMATION OF GRANULOMAS POST-OPERATIVELY. SUBSEQUENTLY, ON (B)(6) 2024, IT WAS REPORTED THAT MEDICAL INTERVENTION WAS REQUIRED TO REMOVE NON-DEGRADED SUTURES, LEADING TO PROLONGED WOUND HEALING AND SCARRING.
Patient problems: Nodule
MAUDE report 20867677 ↗InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON 4 NOVEMBER 2024, THE REPORTER NOTED THE FORMATION OF GRANULOMAS POST-OPERATIVELY. SUBSEQUENTLY, ON (B)(6) 2024, IT WAS REPORTED THAT MEDICAL INTERVENTION WAS REQUIRED TO REMOVE NON-DEGRADED SUTURES, LEADING TO PROLONGED WOUND HEALING AND SCARRING.
Patient problems: Nodule
MAUDE report 20867367 ↗InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2024, THE REPORTER NOTED THE FORMATION OF GRANULOMAS POST-OPERATIVELY. SUBSEQUENTLY, ON (B)(6) 2024, IT WAS REPORTED THAT MEDICAL INTERVENTION WAS REQUIRED TO REMOVE NON-DEGRADED SUTURES, LEADING TO PROLONGED WOUND HEALING AND SCARRING.
Patient problems: Nodule
MAUDE report 20867174 ↗InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2024, THE REPORTER NOTED THE FORMATION OF GRANULOMAS POST-OPERATIVELY. SUBSEQUENTLY, ON (B)(6) 2024, IT WAS REPORTED THAT MEDICAL INTERVENTION WAS REQUIRED TO REMOVE NON-DEGRADED SUTURES, LEADING TO PROLONGED WOUND HEALING AND SCARRING.
Patient problems: Nodule
MAUDE report 20866960 ↗InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2024, THE REPORTER NOTED THE FORMATION OF GRANULOMAS POST-OPERATIVELY. SUBSEQUENTLY, ON (B)(6) 2024, IT WAS REPORTED THAT MEDICAL INTERVENTION WAS REQUIRED TO REMOVE NON-DEGRADED SUTURES, LEADING TO PROLONGED WOUND HEALING AND SCARRING.
Patient problems: Nodule
MAUDE report 20866739 ↗InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON 4 NOVEMBER 2024, THE REPORTER NOTED THE FORMATION OF GRANULOMAS POST-OPERATIVELY. SUBSEQUENTLY, ON (B)(6) 2024, IT WAS REPORTED THAT MEDICAL INTERVENTION WAS REQUIRED TO REMOVE NON-DEGRADED SUTURES, LEADING TO PROLONGED WOUND HEALING AND SCARRING.
Patient problems: Nodule
MAUDE report 20866492 ↗
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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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