ATLAS 11200Recalls & reported problems
Parcus Medical LLC · ATLAS, DT w/ GFS and Drill Bit · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816342024983), received between Feb 5, 2026 and Feb 5, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (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
- Migration1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 5, 2026Migration
PRIMARY SURGERY, PERFORMED ON (B)(6) 2025, INVOLVED A CMC ARTHROPLASTY COMBINED WITH MCP ARTHRODESIS. THE INITIAL POSTOPERATIVE COURSE WAS UNEVENTFUL. HOWEVER, STARTING IN (B)(6) 2025, THE PATIENT REPORTED SWELLING AND PAIN AT THE BASE OF THE THUMB. RADIOGRAPHIC INVESTIGATIONS REVEALED COLLAPSE OF THE THUMB METACARPAL, CONSISTENT WITH A POSSIBLE FAILURE OF THE CMC RECONSTRUCTION. CONSEQUENTLY, A REVISION SURGERY WAS SCHEDULED AND PERFORMED ON (B)(6) 2025.
Patient problems: Pain
MAUDE report 24267168 ↗
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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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