Spline® Twist™ Implant System 1994Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00889024013179), received between Apr 15, 2020 and Dec 2, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2025Premature Separation; Premature Separation

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693752 ↗
• MalfunctionJun 9, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE STRAIGHT HEALING SCREW WAS STUCK IN THE FIXTURE (IMPLANT) AT TOOTH SITE #30 FROM THE MIDDLE AND WOULD NOT GO IN. THEREFORE, THE FIXTURE (IMPLANT) WAS ALSO REMOVED AND THE PROCEDURE WAS COMPLETED USING ANOTHER PRODUCT OF THE SAME SIZE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22166072 ↗
• MalfunctionApr 21, 2025Mechanical Problem; Mechanical Problem

  NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21877203 ↗
• MalfunctionOct 24, 2024Component Missing; Component Missing

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20522334 ↗
• MalfunctionJul 9, 2024Separation Failure; Separation Failure

  NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19702181 ↗
• MalfunctionOct 6, 2023Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE MOUNT AND FIXTURE WERE TIGHTLY CONNECTED AND COULD NOT BE DISENGAGED. IMMEDIATELY RE-IMPLANTED WITH THE SAME TYPE PRODUCT. TOOTH SITE # 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17887933 ↗
• MalfunctionJun 6, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT HEALING SCREW STOPS HALFWAY. AFTER PLACING THE IMPLANT, THE DOCTOR TRIED TO ATTACH THE HEALING SCREW, BUT IT STOPPED HALFWAY. HE TRIED ANOTHER ONE AND IT STOPPED AS WELL. NO HEALTH HAZARD. TOOTH SITE # 18.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17076159 ↗
• MalfunctionJul 8, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE IMPLANT AT LOCATION # 19 WAS REMOVED. THE GINGIVAL CUFF CAN'T BE SCREWED. WE TRIED IT WITH A SAMPLE OF THE GINGIVAL CUFF WE HAVE, BUT IT STOPPED HALFWAY AND DID NOT GO ALL THE WAY IN. THE DOCTOR REMOVED THAT IMPLANT AND PLACED ANOTHER PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14961009 ↗
• MalfunctionDec 10, 2021Positioning Failure; Positioning Failure

  NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12975818 ↗
• MalfunctionNov 24, 2021Fracture; Fracture

  THERE IS NO UPDATE TO THE ORIGINAL COMPLAINT DESCRIPTION PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 12872532 ↗
• MalfunctionNov 6, 2020Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE IMPLANT BODY CANNOT BE REMOVED FROM THE FIXTURE MOUNT. THE IMPLANT WAS REMOVED AND ANOTHER IMPLANT WAS PLACED. TOOTH LOCATION 19.

  Patient problems: No Information

  MAUDE report 10801474 ↗
• MalfunctionApr 15, 2020Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE IMPLANTS BODY CANNOT BE REMOVED FROM THE DELIVERY MOUNTS. THE IMPLANTS WERE REMOVED AND ANOTHER IMPLANTS WERE PLACED. TOOTH LOCATION # 19.

  Patient problems: No Information

  MAUDE report 9962057 ↗
• MalfunctionApr 15, 2020Separation Failure; Separation Failure

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Information

  MAUDE report 9961877 ↗