Geminus GEMINUS Volar Distal Radius Plate, Standard, 4 Hole, LeftRecalls & reported problems
Skeletal Dynamics L.L.C. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841506101590), received between Mar 10, 2021 and Jan 4, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Improper or Incorrect Procedure or Method1
- Misassembly by Users1
Patient problems
- Failure of Implant1
- Foreign Body In Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 4, 2024Fracture; Fracture
AN IMPLANTED GEMINUS DISTAL RADIUS PLATE BROKE 5 MONTHS AFTER SURGERY.
Patient problems: Failure of Implant
MAUDE report 18443035 ↗InjuryMar 10, 2021Improper or Incorrect Procedure or Method; Misassembly by Users; Improper or Incorrect Procedure or Method; Misassembly by Users
FDA REPORT WAS RECEIVED THAT A SMALL PRE-ATTACHED DRILL GUIDE TO THE PLATE WAS INADVERTENTLY LEFT IN PLACE AT THE CONCLUSION OF WRIST SURGERY.
Patient problems: Foreign Body In Patient
MAUDE report 11453733 ↗
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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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