Hex-Lock® HLA4/5Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00889024015210), received between Sep 9, 2021 and May 2, 2024 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (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. 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMay 2, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #16 HAD TO BE REMOVED AS THE CROWN WAS LOOSE DUE TO THE ABUTMENT SCREW FRACTURING. THE IMPLANT WAS REMOVED AFTER TRYING TO REMOVE THE FRACTURED SCREW AND NOT BEING ABLE TO. THE SURGERY WAS COMPLETED WITH ANOTHER IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19231215 ↗
• InjuryMar 22, 2024Fracture; Fracture

  NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18957760 ↗
• InjurySep 8, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT WILL BE SENT BACK TO ORAL SURGEON TO REMOVE THE BROKEN PIECE OF ABUTMENT. THE ABUTMENT AT TOOTH SITE #3 FRACTURED WAS REMOVED. THE HEXAGON PROTRUDING FROM THE BASE OF THE ABUTMENT SHEARED OFF AND IS STUCK IN THE IMPLANT. SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: YES, LASER OF GINGIVAL TISSUE. ADDITIONAL APPOINTMENT REQUIRED: YES, COULD NOT SEAT HEALING CAP PROPERLY. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation

  MAUDE report 15384544 ↗
• MalfunctionAug 31, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED ABUTMENT SCREW SLIP. 1 IMPLANT OF 4.7X8MM WAS IMPLANTED AT THE MISSING TOOTH SITE OF 19 ON (B)(6) 2020. THE ABUTMENT SCREW SLIP WAS FOUND ON (B)(6) 2021. THE CROWN AND THE ABUTMENT WERE REMOVED. THERE WAS NO IMPACT ON IMPLANT. OTHER ABUTMENT HAS BEEN USED TO COMPLETE THE SUBSEQUENT SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15331764 ↗
• InjuryJun 7, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT CAME TO THE CLINIC DUE TO THE LOSS OF RESTORATION. AFTER EXAMINATION, THE BROKEN CENTRAL SCREW OF RESTORATIVE ABUTMENT WAS FOUND. THE BROKEN SCREW COULD NOT BE REMOVED, SO THE IMPLANT AT TOOTH LOCATION #36 WAS THEN REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14623066 ↗
• MalfunctionApr 1, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED LOOSENING SCREW , IT HAS BEEN REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13975323 ↗
• MalfunctionApr 1, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED SCREW LOOSENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13975230 ↗
• MalfunctionNov 19, 2021Separation Failure; Separation Failure

  THERE IS NO UPDATE TO THE ORIGINAL COMPLAINT DESCRIPTION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12844254 ↗
• MalfunctionOct 28, 2021Unintended Movement; Unintended Movement

  WHEN INSTALLING THE ABUTMENT, THE ABUTMENT SCREW STRIPPED. THEY REMOVED THE ABUTMENT DESTRUCTIVELY. NEW ABUTMENT IS ALREADY INSTALLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12715818 ↗
• MalfunctionSep 9, 2021Fracture; Unintended Movement; Fracture; Unintended Movement

  IT WAS REPORTED THAT ABUTMENT LOOSENED, 7 MONTHS AFTER IMPLANTATION, THE PATIENT FELT TOOTH LOOSENING AND CAME TO THE CLINIC FOR RE-EXAMINATION. THE ABUTMENT LOOSENING WAS FOUND. THE ABUTMENT WAS REMOVED AND NEW ABUTMENT WAS PLACED. TOOTH LOCATION # 15.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12450855 ↗