Hex Tool HT1.25Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10841307119609), received between Jul 5, 2019 and Sep 7, 2023 — classified as 12 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (9 reports).

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

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjurySep 7, 2023Fracture; Fracture

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, BROKEN OR FRACTURED COMPONENT WAS OBSERVED

  Patient problems: Failure of Implant

  MAUDE report 17697631 ↗
• InjuryFeb 17, 2023Fracture; Fracture

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, BROKEN OR FRACTURED COMPONENT WAS OBSERVED.

  Patient problems: Failure of Implant

  MAUDE report 16399252 ↗
• InjuryFeb 17, 2023Fracture; Fracture

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, BROKEN OR FRACTURED COMPONENT WAS OBSERVED.

  Patient problems: Failure of Implant

  MAUDE report 16397403 ↗
• InjuryJan 10, 2023Fracture; Fracture

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, BROKEN OR FRACTURED COMPONENT WAS OBSERVED.

  Patient problems: Failure of Implant

  MAUDE report 16128791 ↗
• InjurySep 5, 2022Material Deformation; Material Deformation

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, DEFORMATION WAS OBSERVED.

  Patient problems: Failure of Implant

  MAUDE report 15355350 ↗
• InjuryMay 11, 2022Material Deformation; Material Deformation

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PRODUCT FRACTURED.

  Patient problems: Failure of Implant

  MAUDE report 14366608 ↗
• InjuryMar 24, 2022Fracture; Fracture

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PRODUCT FRACTURE WAS OBSERVED.

  Patient problems: Failure of Implant

  MAUDE report 13891381 ↗
• InjuryMar 7, 2022Loss of Osseointegration; Loss of Osseointegration

  PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PRODUCT FRACTURE WAS OBSERVED.

  Patient problems: Failure of Implant; Granuloma

  MAUDE report 13685244 ↗
• InjuryOct 12, 2021Fracture; Fracture

  PER COMPLAINT (B)(4), PRODUCT FRACTURE WAS OBSERVED.

  Patient problems: Failure of Implant

  MAUDE report 12615130 ↗
• InjuryMay 26, 2021Separation Failure; Osseointegration Problem; Separation Failure; Osseointegration Problem

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PRODUCT FRACTURE WAS OBSERVED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 11884379 ↗
• InjuryOct 22, 2020Fracture; Fracture

  PER COMPLAINT (B)(4), PRODUCT FRACTURED IS EXPERIENCED.

  Patient problems: Failure of Implant

  MAUDE report 10716872 ↗
• InjuryOct 22, 2020Fracture; Fracture

  PER COMPLAINT (B)(4), PRODUCT FRACTURED IS EXPERIENCED.

  Patient problems: Failure of Implant

  MAUDE report 10716870 ↗
• MalfunctionDec 11, 2019Positioning Problem; Positioning Problem

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, THE DRIVER GOT FRACTURED.

  Patient problems: Failure of Implant; No Information

  MAUDE report 9449797 ↗
• MalfunctionNov 28, 2019Defective Device; Defective Device

  PER COMPLAINT (B)(4), HT1.25S AND HT1.25 HEX TOOL BENT WHILE REMOVING HEALING CAP.

  Patient problems: Failure of Implant; No Consequences Or Impact To Patient

  MAUDE report 9389854 ↗
• MalfunctionOct 11, 2019Fracture; Fracture

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE IT WAS OBSERVED THAT THE DRIVER HAD BROKEN WHILE TORQUING IMPLANT.

  Patient problems: Failure of Implant; No Consequences Or Impact To Patient

  MAUDE report 9178184 ↗
• MalfunctionJul 26, 2019Break; Break

  PER COMPLAINT (B)(4), A DENTAL IMPLANT DRIVER SNAPPED IN HALF WHILE THE DENTIST WAS WORKING IN THE PATIENT'S MOUTH. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED .

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8833901 ↗
• 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 8765249 ↗