#2 Uni Pdo 70cm VLP-2010Recalls & reported problems
Surgical Specialties México, S. de R.L. de C.V. · #2 Uni Pdo 70cm · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00848782020782), received between Nov 4, 2025 and Apr 30, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
Patient problems
- Wound Dehiscence2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 30, 2026Break
IT WAS REPORTED ON (B)(6) 2026 THAT THE PATIENT EXPERIENCED WOUND HEALING DIFFICULTY LEADING TO A REVISION SURGERY. DURING THE REVISION SURGERY IT WAS DISCOVERED THE SUTURE BROKE INTO MULTIPLE PIECES INSIDE THE PATIENT. NO ADDITIONAL INFORMATION WAS RECEIVED.
Patient problems: Wound Dehiscence
MAUDE report 25047169 ↗MalfunctionApr 29, 2026Break
IT WAS REPORTED ON 15 APRIL 2026 THAT THE PATIENT EXPERIENCED WOUND HEALING DIFFICULTY LEADING TO A REVISION SURGERY. DURING THE REVISION SURGERY IT WAS DISCOVERED THE SUTURE BROKE INTO MULTIPLE PIECES INSIDE THE PATIENT. NO ADDITIONAL INFORMATION WAS RECEIVED.
Patient problems: Wound Dehiscence
MAUDE report 25037683 ↗InjuryNov 4, 2025Break; Break
IT WAS REPORTED ON (B)(6) 2025 THAT ON (B)(6) 2025 THAT SUTURE BREAK OCCURRED 30 DAYS POSTOPERATIVELY, RESULTING IN A JOINT CAPSULE TEAR AND A SECOND SURGERY WAS PERFORMED. NO ADDITIONAL INFORMATION WAS RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23469443 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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