Spline® Twist™ Implant System 1993Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00889024013162), received between Dec 10, 2021 and Oct 22, 2025 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2025Mechanical Problem; Mechanical Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23361467 ↗
• MalfunctionJun 25, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE MOUNT WAS SO TIGHT THAT IT WOULDN'T COME OFF OF THE IMPLANT AT TOOTH SITE #30. THE IMPLANT WAS REPLACED WITH ANOTHER OF THE SAME TYPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22327519 ↗
• MalfunctionAug 12, 2024Separation Failure; Separation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19967300 ↗
• MalfunctionMar 22, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE DISTRIBUTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE TO REQUESTS FOR INVESTIGATION. UPON INVESTIGATION, A MALFUNCTION WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18959190 ↗
• InjurySep 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED PERI-IMPLANTITIS AND LOSS OF INTEGRATION AT THE IMPLANT AT TOOTH LOCATION #3. THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: EDEMA, INFLAMMATION, INFECTION, BONE LOSS.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 17842239 ↗
• InjuryJul 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT REPORTED A MOBILE IMPLANT AT TOOTH LOCATION #3. THE IMPLANT LOST INTEGRATION DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 17414711 ↗
• InjuryDec 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT FOR SITE 2 WAS REMOVED DUE TO PERI-IMPLANTITIS. THE SITE WAS GRAFTED WITH ALLOGRAFT PRIOR TO ORIGINAL IMPLANT PLACEMENT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 16043355 ↗
• MalfunctionJun 23, 2022Separation Failure; Separation Failure

  DOCTOR INDICATED MALFUNCTION. THE IMPLANT BODY CANNOT BE REMOVED FROM THE FIXTURE MOUNT. THE IMPLANT WAS REMOVED AND ANOTHER IMPLANT WAS PLACED. TOOTH SITE # 14 (UNIVERSAL).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14789133 ↗
• InjuryJun 15, 2022Mechanical Problem; Mechanical Problem

  DOCTOR INDICATED MALFUNCTION. THE IMPLANT BODY CANNOT BE REMOVED FROM THE FIXTURE MOUNT. THE PHYSICIAN REMOVED THE IMPLANT FROM THE PATIENT'S MOUTH. NO OTHER IMPLANT PLACED. TOOTH SITE # 30 (UNIVERSAL).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14700999 ↗
• MalfunctionDec 10, 2021Separation Failure; Separation Failure

  NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12975684 ↗