Spline® Twist™ Implant System 2120Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00889024013261), received between Sep 10, 2020 and Apr 17, 2025 — classified as 9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE GINGIVAL CUFF WON'T FIT. AFTER PLACING THE 2120 IMPLANT, THREE GINGIVAL CUFFS WERE TRIED, BUT THEY ONLY WENT IN PARTWAY. WHEN A DIFFERENT IMPLANT WAS SUBSTITUTED, THE GINGIVAL CUFF WAS ABLE TO BE ATTACHED IMMEDIATELY. THE DOCTOR IS REQUESTING AN INVESTIGATION, AS THE INTERNAL THREAD OF THE IMPLANT MAY BE DEFECTIVE. HE IS REQUESTING AN ANSWER AS TO WHY THE GINGIVAL CUFF CANNOT BE ATTACHED. THE SALES REPRESENTATIVE REPORTED THAT THE GINGIVAL CUFF USED WAS EITHER 1806, 1807, 1808, OR 1809. PROCEDURE COMPLETED USING ANOTHER IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21855409 ↗
• MalfunctionJan 25, 2024Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE MOUNT AT IMPLANT TOOTH SITE #20 COULD NOT BE REMOVE. THE DOCTOR PLACED THE 2120 IMPLANT, BUT THE MOUNT WAS STIFF AND WOULDN'T COME OFF. THE DOCTOR REPLACED THE SPLINE WITH A DIFFERENT SIZE AND REQUESTED AN INVESTIGATION AND HOPPING THAT SIMILAR PROBLEMS WILL BE ELIMINATED AS SOON AS POSSIBLE. THE PROCEDURE WAS COMPLETED USING ANOTHER IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18584872 ↗
• MalfunctionNov 9, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE IMPLANT ON TOOTH SITE #3 DID NOT FIT INTO THE HEALING CAP. IT WAS REMOVED AND REPLACED WITH ANOTHER IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15764052 ↗
• MalfunctionSep 2, 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 # 18 (UNIVERSAL).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15348617 ↗
• MalfunctionAug 8, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT AT THE TIME OF IMPLANT PLACEMENT, THE HEALING SCREW WAS UNABLE TO BE SEATED ON THE IMPLANT AND THEREFORE THE IMPLANT WAS REMOVED AND A NEW IMPLANT WAS PLACED.

  Patient problems: Insufficient Information

  MAUDE report 15188084 ↗
• MalfunctionApr 22, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE HEALING CAP CAN'T BE SCREWED. THE IMPLANT WAS REMOVED AND ANOTHER IMPLANT WAS PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14187555 ↗
• MalfunctionDec 1, 2021Positioning Failure; Positioning Failure

  THERE IS NO UPDATE TO THE ORIGINAL COMPLAINT DESCRIPTION PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 12908757 ↗
• MalfunctionOct 1, 2021Separation Failure; Separation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12562711 ↗
• MalfunctionSep 10, 2020Separation Failure; Separation Failure

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

  Patient problems: No Information

  MAUDE report 10514318 ↗