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RELIANCE LITe 48060500Recalls & reported problems

Stryker Corporation · STRAIGHT OSTEOTOME · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327263381), received between Aug 21, 2017 and Aug 21, 2017 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1
  • Material Deformation1
  • Material Integrity Problem1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionAug 21, 2017Material Deformation; Material Integrity Problem; Break; Material Deformation; Material Integrity Problem

    IT WAS REPORTED THAT; THE SCRUB NURSE NOTICED THE OSTEOTOME APPEARED CHIPPED AFTER IT WAS USED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6809357 ↗

Other INSTRUMENT, SURGICAL, NON-POWERED devices

All INSTRUMENT, SURGICAL, NON-POWERED devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.