RELIANCE LITe 48060907Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327263534), received between Jul 6, 2018 and Jul 6, 2018 — classified as 1 malfunction.

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.

• MalfunctionJul 6, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT A PADDLE DISTRACTOR BROKE WITHIN THE PATIENT'S DISC SPACE. HOWEVER, UPON FURTHER COMMUNICATION IT WAS CONFIRMED THAT THE INSTRUMENT WAS ACTUALLY A CUSTOM SHAVER THAT BROKE. THE SURGEON REPORTED THAT NO EXCESS TORQUE WAS APPLIED TO THE INSTRUMENT DURING USE. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED WITH A SURGICAL DELAY OF 2 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7667801 ↗