2-0 Uni Pdo 15cm VLP-2021Recalls & reported problems
Surgical Specialties México, S. de R.L. de C.V. · 2-0 Uni Pdo 15cm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00848782023660), received between Apr 9, 2024 and May 12, 2025 — classified as 5 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Separation Problem” (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
- Separation Problem6
- Detachment of Device or Device Component4
Patient problems
- No Clinical Signs, Symptoms or Conditions9
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryMay 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED ON (B)(6) 2025 THAT A NEEDLE DETACHED FROM A SUTURE INTRAOPERATIVELY. NO PATIENT INJURY OCCURRED; HOWEVER, THERE WAS A PROCEDURAL DELAY, AND INTERVENTION WAS REQUIRED TO RETRIEVE THE NEEDLE FROM THE PATIENT. NO ADDITIONAL PROCEDURE WAS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22006203 ↗InjuryMay 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED ON (B)(6) 2025 THAT A NEEDLE DETACHED FROM THE SUTURE 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 21945958 ↗InjuryMay 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED ON (B)(6) 2025 THAT A NEEDLE DETACHED FROM THE SUTURE 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 21945843 ↗InjuryJan 30, 2025Detachment of Device or Device Component; Separation Problem; Detachment of Device or Device Component; Separation Problem
IT WAS REPORTED ON (B)(6) 2025 THAT A NEEDLE DETACHED FROM A SUTURE INTRAOPERATIVELY. NO PATIENT INJURY OCCURRED; HOWEVER, THERE WAS A PROCEDURAL DELAY, AND INTERVENTION WAS REQUIRED TO RETRIEVE THE NEEDLE FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21279992 ↗InjurySep 4, 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 PROCEDURAL DELAY GREATER THAN 30 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20138092 ↗MalfunctionSep 3, 2024Separation Problem; Separation Problem
ON 5 AUG 2024, IT WAS REPORTED THAT DURING MULTIPLE LAPAROSCOPIC HERNIA PROCEDURES, THE THREAD DETACHED FROM THE NEEDLE. ADDITIONAL INFORMATION RECEIVED ON 13 AUG 2024 INDICATED THAT THE BREAKING OF THE THREAD REQUIRED INTERVENTION, WHICH EXTENDED THE OPERATION TIME BY OVER 30 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20127690 ↗MalfunctionSep 3, 2024Separation Problem; Separation Problem
ON (B)(6) 2024, IT WAS REPORTED THAT DURING MULTIPLE LAPAROSCOPIC HERNIA PROCEDURES, THE THREAD DETACHED FROM THE NEEDLE. ADDITIONAL INFORMATION RECEIVED ON 13 AUG 2024 INDICATED THAT THE BREAKING OF THE THREAD REQUIRED INTERVENTION, WHICH EXTENDED THE OPERATION TIME BY OVER 30 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20127687 ↗MalfunctionSep 3, 2024Separation Problem; Separation Problem
ON (B)(6) 2024, IT WAS REPORTED THAT DURING MULTIPLE LAPAROSCOPIC HERNIA PROCEDURES, THE THREAD DETACHED FROM THE NEEDLE. ADDITIONAL INFORMATION RECEIVED ON 13 AUG 2024 INDICATED THAT THE BREAKING OF THE THREAD REQUIRED INTERVENTION, WHICH EXTENDED THE OPERATION TIME BY OVER 30 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20127677 ↗MalfunctionApr 9, 2024Separation Problem; Separation Problem
THE NEEDLE DISLODGED FROM THE SUTURE INSIDE THE PATIENT'S ABDOMEN DURING LAPAROSCOPIC SURGERY. NO OTHER DETAILS COULD BE OBTAINED TO DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19068873 ↗
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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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