Tapered Hex Tool THT1.25Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10841307119494), received between Jul 5, 2019 and Jul 5, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Integrity Problem” (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 16, 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 5, 2019Material Integrity Problem; Material Integrity Problem

  PER COMPLAINT (B)(4), DURING THE CLINICAL PROCEDURE, THE DOCTOR COULD NOT REMOVE THE IMPRESSION POST AND STRIPPED 3 DRIVERS. PER THE COMPLAINT, THE DOCTOR STATES THAT HE DID NOT USE A TORQUE WRENCH TO TIGHTEN SCREW BUT WHEN HE TRIED TO REMOVE THE SCREW FROM THE IMPLANT IT WAS STUCK. HE HAS STRIPPED OR BROKEN MULTIPLE TIPS AND TRIED THE ULTRA SONIC TO TRY TO BREAK UP ANYTHING WEDGING THE ABUTMENT IN PLACE, NOTHING WORKED. ADDITIONALLY, THE DOCTOR HAS APPLIED TO UP TO 60 NCM OF COUNTERCLOCKWISE TORQUE AND THE SCREW WOULDN'T MOVE. THE IMPLANT WAS EXTRACTED.

  Patient problems: No Information

  MAUDE report 8765254 ↗