Skip to content

ERISMA® LP_NAVIGATED INSTRUMENTS 48710003Recalls & reported problems

Clariance · ERISMA-LP NAV SCREWDRIVER · Class 2

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 03700780638222), received between Jul 21, 2021 and Jul 21, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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

  • Material Fragmentation1

Patient problems

  • Insufficient Information1

Recent adverse event reports

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

  • MalfunctionJul 21, 2021Material Fragmentation; Material Fragmentation

    BOTH SCREWDRIVERS AVAILABLE IN ERISMA-LP NAVIGATED INSTRUMENTS WOULD NOT DISENGAGE FROM THE SCREW WHILE BEING IMPLANTED. IT WAS DISASSEMBLED AND REASSEMBLED BY "STERILE PROCESSING DEPARTMENT" INCORRECTLY, CAUSING THE LOCKING MECHANISM TO FUNCTION ABNORMALLY. THE SURGEON HAD TO USE A DIFFERENT SYSTEM DELAYING THE SURGERY BY 30 MINUTES.

    Patient problems: Insufficient Information

    MAUDE report 12207186 ↗

Other Orthopedic Stereotaxic Instrument devices

All Orthopedic Stereotaxic Instrument devices →

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