SIros Navigated Instruments 1Recalls & reported problems
Genesys Orthopedics Systems LLC · 9.5mm SI Navigated Drill · Class 2
Data updated Oct 13, 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 M719GSI2450950), received between Jun 16, 2025 and Jun 16, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Mechanical Jam” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Mechanical Jam1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 16, 2025Mechanical Problem; Mechanical Jam; Mechanical Problem; Mechanical Jam
AN CLAMP ADAPTER JAMMED WITH A SIROS 9.5MM NAVIGATED DRILL INTRA-OPERATIVELY. THE PROCEDURE WAS UNABLE TO BE COMPLETED AS PLANNED AND WILL BE RESCHEDULED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22214935 ↗
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- Firebird SI Fusion 18-2040SPOrthofix US LLC · Sacroiliac Joint Fixation1 recall0 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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