Geminus Driver, AO Connection, Polyaxial Locking ScrewRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841506101286), received between Jul 16, 2020 and Jul 20, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2020Break; Fracture; Break; Fracture

  USER SUBMITTED A REPORT TO THE FDA STATING: WHILE PLATING A VARIABLE ANGLE SCREW, THE TIP OF THE DRIVER COLD WELDED IN THE HEAD OF THE SCREW AND BROKE OFF. DECISION WAS MADE TO LEAVE THE TIP OF THE DRIVER IN THE SCREW HEAD, AS SCREW HAD GOOD PLACEMENT AND TIP WAS COLD WELDED WITHOUT POSSIBILITY OF MIGRATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10299817 ↗
• InjuryJul 16, 2020Break; Material Fragmentation; Break; Material Fragmentation

  USER SUBMITTED A REPORT TO THE FDA STATING: DURING PLACEMENT OF A LOCKING SCREW, THE TIP OF A SCREWDRIVER BROKE FLUSH INTO THE HEAD OF X1 LOCKING SCREW. ATTEMPTS WERE MADE TO REMOVE THE BROKEN SCREWDRIVER TIP FROM THE HEAD OF THE LOCKING SCREW. THIS COULD NOT BE ACHIEVED AS THE TIP WAS INCARCERATED WITHIN THE HEAD OF THE LOCKING SCREW.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10282935 ↗