Spline Twist Implant SystemRecalls & reported problems across all models
ZimVie US Corp LLC · 14 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 97
- Deaths reported
- 0
- Injuries reported
- 24
- Recalls
- 0
We found 14 models of Spline Twist Implant System by ZimVie US Corp LLC in the FDA's device registry (GUDID). Together they are named in 97 adverse event reports in the FDA's MAUDE database, received between Apr 15, 2020 and Sep 28, 2026 — classified as 24 injuries, 73 malfunctions.
The most frequently reported specific device problem is “Separation Failure” (52 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Spline Twist Implant System problems
Device problems
- Separation Failure52
- Adverse Event Without Identified Device or Use Problem20
- Mechanical Problem13
- Fracture4
- Positioning Failure4
- Component Missing1
- Detachment of Device or Device Component1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions62
- Unspecified Infection18
- Osteolysis12
- No Information8
- Pain7
- Insufficient Information6
- Inflammation5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Spline Twist Implant System models
14 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Spline® Twist™ Implant System 1988IMPLANT, ENDOSSEOUS, ROOT-FORM23 reports
- Spline® Twist™ Implant System 1989IMPLANT, ENDOSSEOUS, ROOT-FORM22 reports
- Spline® Twist™ Implant System 1994IMPLANT, ENDOSSEOUS, ROOT-FORM13 reports
- Spline® Twist™ Implant System 1993IMPLANT, ENDOSSEOUS, ROOT-FORM10 reports
- Spline® Twist™ Implant System 2120IMPLANT, ENDOSSEOUS, ROOT-FORM9 reports
- Spline® Twist™ Implant System 2130IMPLANT, ENDOSSEOUS, ROOT-FORM6 reports
- Spline® Twist™ Implant System 2131IMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- Spline® Twist™ Implant System 1960IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- Spline® Twist™ Implant System 1980IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- Spline® Twist™ Implant System 1981IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- Spline® Twist™ Implant System 2121IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- Spline® Twist™ Implant System 1990IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- Spline® Twist™ Implant System 1991IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- Spline® Twist™ Implant System 2133IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
Recent Spline Twist Implant System adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 ↗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 ↗MalfunctionMar 3, 2026Fracture; Mechanical Problem
THE DISTRIBUTOR CONFIRMED WHAT THE INVESTIGATION FOUND. THE IMPLANT FINGERS ARE NOT ACTUALLY FRACTURED, JUST BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24497272 ↗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 ↗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 ↗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 ↗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 ↗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 ↗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 ↗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 ↗
Other ZimVie US Corp LLC products
- Tapered Screw-Vent131 models · 13,236 reports · 4 recalls
- OSSEOTITE CERTAIN74 models · 1,891 reports · 1 recall
- TSX Implants28 models · 1,279 reports
- OSSEOTITE73 models · 894 reports
- 3i T3 DCD73 models · 789 reports
- OSSEOTITE CERTAIN PREVAIL15 models · 785 reports
- CERTAIN BELLATEK12 models · 9 reports · 10 recalls
- Eztetic15 models · 382 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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