Hex Tool HT2.5Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10841307119630), received between Mar 14, 2018 and Feb 21, 2023 — classified as 5 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (5 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 21, 2023Fracture; Fracture

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

  Patient problems: Failure of Implant

  MAUDE report 16408238 ↗
• InjuryFeb 20, 2023Fracture; Fracture

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

  Patient problems: Failure of Implant

  MAUDE report 16402448 ↗
• MalfunctionJul 14, 2021Fracture; Fracture

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

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 12165873 ↗
• MalfunctionFeb 5, 2021Failure to Osseointegrate; Failure to Osseointegrate

  PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.

  Patient problems: Failure of Implant

  MAUDE report 11285556 ↗
• MalfunctionMar 5, 2020Separation Failure; Separation Failure

  PER COMPLAINT (B)(4), COMPONENTS COULD NOT BE SEPARATED. THERE WAS NO PATIENT IMPACT NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9793628 ↗
• InjuryDec 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  PER COMPLAINT (B)(4), HEX TOOL HT2.5 MALFUNCTIONED RESULTING IN FAILURE OF INTEGRATION.

  Patient problems: Failure of Implant; No Information

  MAUDE report 9529384 ↗
• MalfunctionDec 20, 2019Failure to Osseointegrate; Failure to Osseointegrate

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, THE COMPONENTS COULD NOT BE SEPARATED

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

  MAUDE report 9501787 ↗
• MalfunctionOct 11, 2019Material Deformation; Material Deformation

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, DRIVER SPUN IN THE IMPLANT BODY WHICH APPEARED TO BE STRIPPED.

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

  MAUDE report 9178116 ↗
• MalfunctionJun 4, 2019Separation Failure; Separation Failure

  PER COMPLAINT (B)(4), AFTER A DENTAL IMPLANT ANALOG WAS REMOVED, A HEX TOOL WAS USED TO DRIVE A DENTAL IMPLANT INTO THE PATIENT'S CREATED SOCKET. THE HEX TOOL GOT STUCK TO THE IMPLANT, WHICH CAUSED THE IMPLANT TO LOOSEN. TWO FORCEPS WERE USED TO SEPARATE THE IMPLANT FROM THE HEX TOOL OUTSIDE OF THE PATIENT'S MOUTH. A DIFFERENT IMPLANT WAS PLACED IN THE PATIENT'S MOUTH WITHIN THE SAME DAY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Failure of Implant; No Information

  MAUDE report 8667462 ↗
• MalfunctionMay 24, 2019Separation Failure; Separation Failure

  PER COMPLAINT (B)(4), THE TORQUE DRIVER WOULD NOT DISENGAGE FROM A DENTAL IMPLANT DURING INITIAL PLACEMENT. THE IMPLANT WAS REMOVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8641254 ↗
• MalfunctionMay 9, 2019Separation Failure; Separation Failure

  PER COMPLAINT (B)(4), A HEX TOOL GOT STUCK WITHIN A DENTAL IMPLANT DURING INITIAL PLACEMENT. THE IMPLANT WAS REMOVED. THE PROCEDURE WAS COMPLETED WITHIN THE SAME VISIT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

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

  MAUDE report 8597190 ↗
• InjuryApr 24, 2019Separation Failure; Separation Failure

  PER COMPLAINT (B)(4), THE INSERTION INSTRUMENT BECAME WEDGED WITH THE IMPLANT SYSTEM DURING THE OPERATION. WHEN THE IMPLANT BECAME RELEASED, THE BONE LAMELLA WALLS WERE DAMAGED. OSTEOPENIA WAS ALSO REPORTED. THE IMPLANT WAS EXTRACTED.

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis

  MAUDE report 8545548 ↗
• MalfunctionOct 11, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  PER COMPLAINT (B)(4), A HEX TOOL BECAME STUCK INSIDE THE IMPLANT DURING PLACEMENT. THE TOOL COULD NOT BE REMOVED. AS A RESULT, THE IMPLANT WAS REMOVED AND A DIFFERENT IMPLANT WAS PLACED USING ANOTHER TOOL.

  Patient problems: Failure of Implant; No Information

  MAUDE report 7956744 ↗
• MalfunctionOct 11, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  PER COMPLAINT (B)(4), A HEX TOOL BECAME STUCK INSIDE THE IMPLANT DURING PLACEMENT. THE TOOL COULD NOT BE REMOVED. AS A RESULT, THE IMPLANT WAS REMOVED AND A DIFFERENT IMPLANT WAS PLACED USING ANOTHER TOOL.

  Patient problems: Failure of Implant; No Information

  MAUDE report 7956737 ↗
• InjuryMay 23, 2018Device-Device Incompatibility; Device-Device Incompatibility

  ACCORDING TO THE COMPLAINT, HEX DRIVERS STUCK TO IMPLANT DURING A PROCEDURE AND REQUIRED SO MUCH FORCE TO DISENGAGE THAT IT REMOVED IMPLANT, COULDN'T BE ENGAGED AGAIN. THIS IS A REPORTABLE SERIOUS INJURY.

  Patient problems: Failure of Implant; No Code Available; Osteopenia/ Osteoporosis

  MAUDE report 7538733 ↗
• MalfunctionMar 14, 2018Device-Device Incompatibility; Device-Device Incompatibility

  PER COMPLAINT NO. (B)(4), COMPLAINANT REPORTED THAT DURING HAND TIGHTENING WITH RATCHET DURING IMPLANT PLACEMENT, DRIVER BECAME STUCK IN IMPLANT AND IMPLANT CAME OUT OF OSTEOTOMY. CONTRAINDICATIONS INCLUDE SMOKING AND THE PATIENT WAS (B)(6) YEARS OF AGE. THIS IS A SUPPLEMENTAL REPORT TO 3001617766-2018-00044 WHICH CAPTURED THE POTENTIALLY MALFUNCTIONING DENTAL IMPLANT REPORTED IN THIS INCIDENT IN COMPLAINT NO. (B)(4). THIS REPORT CAPTURES THE COMPLAINT AGAINST A POTENTIALLY MALFUNCTIONING HEX TOOL USED DURING THE FAILED OSTEOMOTOMY.

  Patient problems: No Code Available

  MAUDE report 7340173 ↗