PiGalileo / TC-PLUS / RT-PLUS 75009338Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07611996100525), received between Jan 4, 2021 and Jan 4, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 4, 2021Break; Break

  IT WAS REPORTED THAT, AFTER SURGERY HAD BEEN PERFORMED, THE POST-OP X-RAYS SHOWED THAT THE TIP OF THE DRILL PIN HAD SNAPPED INSIDE OF THE TIBIA AND IS STILL IN SITU. IT IS UNKNOWN IF A REVISION SURGERY WILL BE PERFORMED TO RETRIEVE THE PIECE. IT IS ALSO UNKNOWN THE CURRENT STATUS OF THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 11112561 ↗