0 Uni Pdo 30cm VLP-1002Recalls & reported problems
Surgical Specialties México, S. de R.L. de C.V. · 0 Uni Pdo 30cm · Class 2 · Implant
Data updated Oct 13, 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 00848782020607), received between Aug 23, 2024 and Sep 13, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Material Separation1
- Separation Problem1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 13, 2024Material Separation; Material Separation
IT WAS REPORTED ON (B)(6) 2024 THAT A SUTURE BROKE 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 20215375 ↗InjuryAug 23, 2024Detachment of Device or Device Component; Separation Problem; Detachment of Device or Device Component; Separation Problem
ON AUGUST 02, 2024 IT WAS REPORTED THAT ON (B)(6) 2024 DURING A SURGICAL PROCEDURE THE NEEDLE CHANNEL BROKE LEADING TO THE NEEDLE FALLING INTO THE PATIENT. THE SURGEON SEARCHED FOR THE NEEDLE FOR OVER AN HOUR AND COULD NOT LOCATE IT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 20050608 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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