NA 02.130.351Recalls & reported problems
Synthes GmbH · 2.0MM VAL STRAIGHT PLATE 12 HOLES · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982045331), received between Aug 4, 2021 and Sep 16, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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. 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
- Device-Device Incompatibility1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON UNKNOWN DATE THE TWO VA HANDS WERE IMPLANTED THEN UNPLANTED. THE SCREWS WOULD NOT LOCK INTO PLATE. THERE WAS NO PATIENT CONSEQUENCES. NO OTHER INFORMATION WAS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20228452 ↗MalfunctionAug 4, 2021Material Deformation; Material Deformation
IT WAS REPORTED THAT ON (B)(6) 2021, A 12 HOLE PLATE WAS DISCOVERED AS BENT. NO PATIENT WAS INVOLVED. THIS REPORT IS FOR ONE (1) 2.0MM VAL STRAIGHT PLATE 12 HOLES THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12274166 ↗
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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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