Spline® Twist™ Implant System 1989Recalls & reported problems
ZimVie US Corp LLC · Class 2 · Implant
All models of Spline Twist Implant System (14)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00889024013124), received between Sep 11, 2020 and Sep 14, 2026 — classified as 4 injuries, 18 malfunctions.
The most frequently reported specific device problem is “Separation Failure” (16 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.
Reports received per month
Most reported problems
Device problems
- Separation Failure16
- Adverse Event Without Identified Device or Use Problem3
- Mechanical Problem2
- Separation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- No Information3
- Insufficient Information2
- Unspecified Infection2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Nerve Damage1
- Pain1
- Swelling/ Edema1
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
it was reported that the doctor had followed the surgical procedures to place the implant in 1989 at tooth site 15. Three weeks after the procedure, the patient developed an infection.
Patient problems: Unspecified Infection
MAUDE report 50751413 ↗MalfunctionMar 5, 2026Separation Failure
IT WAS REPORTED THAT DURING PLACEMENT OF THE IMPLANT AT TOOTH SITE #5, THE MOUNT WAS TOO TIGHT AND COULD NOT BE REMOVED. THE DENTIST ADDRESSED THE ISSUE USING AN IDENTICAL PRODUCT FROM INVENTORY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24518031 ↗InjuryJul 16, 2025Separation Failure; Separation Failure
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22522151 ↗MalfunctionJul 16, 2025Separation Failure; Separation Failure
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22518948 ↗MalfunctionFeb 14, 2025Separation Failure; Separation Failure
IT WAS REPORTED STUCK MOUNT. THE SCREW WAS SO TIGHT THAT IT COULD NOT BE REMOVED. THEREFORE, THE SAME SIZE FIXTURE WAS RE-IMPLANTED. THE DOCTOR STRONGLY CLAIMED THAT IT WAS A PRODUCT DEFECT. HE REQUESTED AN INVESTIGATION INTO THE CAUSE AND A RESPONSE. TOOTH SITE # 4. PROCEDURE WAS COMPLETED USING ANOTHER IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21388302 ↗MalfunctionDec 2, 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 20819233 ↗MalfunctionDec 2, 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 20819204 ↗InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION. THE DOCTOR FOLLOWED THE SPLINE SURGICAL PROCEDURES TO PLACE THE IMPLANT - 1989. AFTER 3 WEEKS, INFECTION WAS HAPPENED TO THE PATIENT. TOOTH SITE # 16. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, EDEMA.
Patient problems: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 20529565 ↗MalfunctionOct 18, 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 20485990 ↗MalfunctionFeb 6, 2024Separation Failure; Separation Failure
IT WAS REPORTED THAT IMPLANT CAN'T COME OFF THE MOUNT. THE DOCTOR REMOVED BECAUSE THE MOUNT BECAUSE IT WOULDN'T COME OFF. TREATMENT COMPLETED WITH ANOTHER SAME PRODUCT. TOOTH SITE # 10.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18655392 ↗MalfunctionOct 10, 2023Separation Failure; Separation Failure
NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17907473 ↗InjurySep 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Nerve Damage
MAUDE report 17699770 ↗MalfunctionMar 8, 2023Separation Failure; Separation Failure
NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16501411 ↗MalfunctionMay 13, 2022Mechanical Problem; Mechanical Problem
DOCTOR INDICATED MALFUNCTION. THE HEALING CAP CAN'T BE SCREWED. THE IMPLANT AT TOOTH SITE #31 WAS REMOVED AND ANOTHER IMPLANT WAS PLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14397397 ↗MalfunctionJan 7, 2022Separation Problem; Separation Problem
IT WAS REPORTED THAT AFTER PLACING THE IMPLANT, THE HEALING SCREW STOPPED IN THE MIDDLE AND COULD NOT BE INSTALLED UNTIL THE END AS IT GOT STUCK. THE IMPLANT WAS REMOVED AND REPLACED WITH A NEW ONE IN THE SAME PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 13192248 ↗MalfunctionJan 4, 2022Separation Failure; Separation Failure
THERE IS NO UPDATE TO THE ORIGINAL COMPLAINT DESCRIPTION PROVIDED.
Patient problems: Insufficient Information
MAUDE report 13158581 ↗MalfunctionAug 18, 2021Separation Failure; Separation Failure
DURING THE INVESTIGATION PROCESS, AFTER VISUAL INSPECTION, FRACTURED/BROKEN SPLINE ON IMPLANT WAS ALSO IDENTIFIED AND CAPTURED IN THE INVESTIGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12338829 ↗MalfunctionJul 16, 2021Separation Failure; Separation Failure
NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12181280 ↗MalfunctionApr 8, 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 11638223 ↗MalfunctionJan 20, 2021Separation Failure; Separation Failure
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Information
MAUDE report 11205928 ↗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 29.
Patient problems: No Information
MAUDE report 10801362 ↗MalfunctionSep 11, 2020Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT DURING IMPLANT PLACEMENT THE IMPLANT FIXTURE MOUNT WAS UNABLE TO DISENGAGE FROM THE IMPLANT (1989). IMPLANT WAS REMOVED AND ANOTHER IMPLANT WAS PLACED INSTEAD. TOOTH LOCATION 15.
Patient problems: No Information
MAUDE report 10524907 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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