2-0 Uni Monoderm 20cm VLM-2006Recalls & reported problems
Surgical Specialties México, S. de R.L. de C.V. · 2-0 Uni Monoderm 20cm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00848782020508), received between Sep 13, 2024 and Oct 31, 2024 — classified as 4 injuries.
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
- Break1
- Separation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryOct 31, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED ON (B)(6) 2024 THAT A NEEDLE DETACHED FROM A SUTURE INTRAOPERATIVELY. NO PATIENT INJURY WAS REPORTED; HOWEVER, INTERVENTION WAS REQUIRED, AND THE NEEDLE WAS RETRIEVED AND REMOVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20580877 ↗InjuryOct 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED ON 16 AUG 2024 THAT A NEEDLE DETACHED FROM A SUTURE INTRAOPERATIVELY. NO PATIENT INJURY WAS REPORTED; HOWEVER, INTERVENTION WAS REQUIRED, AND THE NEEDLE WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20359778 ↗InjurySep 15, 2024Break; Break
IT WAS REPORTED ON (B)(6) 2024 THAT A NEEDLE BROKE INTRAOPERATIVELY. THE NEEDLE WAS SUCCESSFULLY REMOVED FROM THE SITE AND NO PATIENT INJURY WAS REPORTED; HOWEVER, THE FAILURE RESULTED IN A SIGNIFICANT PROCEDURAL DELAY AND INTERVENTION WAS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20220921 ↗InjurySep 13, 2024Separation Problem; Separation Problem
IT WAS REPORTED ON (B)(6) 2024 THAT A NEEDLE DETACHED FROM A SUTURE INTRAOPERATIVELY. NO PATIENT INJURY WAS REPORTED; HOWEVER, INTERVENTION WAS REQUIRED, WHICH RESULTED IN A SIGNIFICANT PROCEDURAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20214244 ↗
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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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