Spline® Twist™ Implant System 1988Recalls & 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
- 23
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00889024013117), received between Aug 3, 2021 and Sep 28, 2026 — classified as 8 injuries, 15 malfunctions.
The most frequently reported specific device problem is “Separation Failure” (14 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 Failure14
- Adverse Event Without Identified Device or Use Problem7
- Fracture1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- Unspecified Infection7
- Osteolysis4
- Pain2
- Inflammation1
- Insufficient Information1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported implant dislodgement due to peri-implantitis. Tooth site 13.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50914301 ↗InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem
The doctor followed the Spline surgical procedures to place the implant (1988) at site #14. Three weeks after placement, the patient developed an infection accompanied by pain and inflammation.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 50303633 ↗InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #29 WAS REMOVED DUE TO IMPLANT MOBILITY ASSOCIATED WITH PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25083269 ↗MalfunctionSep 19, 2025Separation Failure; Separation Failure
IT WAS REPORTED THAT AFTER PLACEMENT, THE IMPLANT MOUNT COULD NOT BE REMOVED FROM THE IMPLANT AT TOOTH SITE #5, SO IT WAS IMMEDIATELY REMOVED AND ANOTHER IMPLANT WAS PLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23097280 ↗InjuryJul 21, 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 22555416 ↗MalfunctionJul 8, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE MOUNT CAN NOT BE REMOVED FROM THE IMPLANT AT TOOTH LOCATION #14. THE IMPLANT WAS REMOVED AND ANOTHER IMPLANT WAS PLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22440989 ↗MalfunctionOct 10, 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 20416495 ↗MalfunctionJun 7, 2024Separation Failure; Separation Failure
IT WAS REPORTED THAT THE DOCTOR IMPLANTED THE FIXTURE, BUT THE MOUNT WOULDN'T COME OFF. FINISHED WITH ANOTHER FIXTURE. TOOTH SITE # 30.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19481924 ↗InjuryJan 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DOCTOR FOLLOWED THE SURGICAL PROCEDURES TO PLACE THE IMPLANT. AFTER 3 WEEKS, THE IMPLANT WAS REMOVED DUE TO INFECTION. TOOTH SITE # 15 (PALMER). SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Pain; Unspecified Infection
MAUDE report 18567368 ↗MalfunctionDec 2, 2023Separation Failure; Separation Failure
NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18253277 ↗InjuryDec 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Unspecified Infection
MAUDE report 18244908 ↗InjuryMar 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH #19 WERE REMOVED DUE TO INFECTION.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 16567181 ↗InjuryNov 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI IMPLANTITIS. TOOTH SITE #14. SITE WAS GRAFTED WITH ALLOGRAFT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 15764517 ↗MalfunctionApr 27, 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 # 31 (UNIVERSAL).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14219540 ↗MalfunctionApr 6, 2022Separation Failure; Separation Failure
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14025534 ↗MalfunctionMar 9, 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 # 31 (UNIVERSAL).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13710948 ↗MalfunctionJan 4, 2022Separation Failure; Separation Failure
IT WAS REPORTED THAT THE IMPLANT MOUNT WAS UNABLE TO BE REMOVED FROM THE IMPLANT AT THE TIME OF PLACEMENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE.
Patient problems: Insufficient Information
MAUDE report 13157557 ↗MalfunctionSep 29, 2021Fracture; Fracture
THE DOCTOR NOTICED THAT THE FIXTURE MOUNT WAS LOOSE BEFORE THE IMPLANT WAS PLACED. HOWEVER, WHEN THE IMPLANT WAS PLACED IN THAT CONDITION, THE SLOT PART OF THE FIXTURE MOUNT AND THE TINE PART OF THE IMPLANT BODY RUPTURED. THE DOCTOR STOPPED USING THE IMPLANT AND PLACED ANOTHER IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12549915 ↗MalfunctionSep 21, 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 12509497 ↗MalfunctionAug 3, 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 12271837 ↗MalfunctionAug 3, 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 12270513 ↗MalfunctionAug 3, 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 12270476 ↗MalfunctionAug 3, 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 12270346 ↗
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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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