Spline® Twist™ Implant System 2130Recalls & 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
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024013285), received between Oct 16, 2020 and Mar 3, 2026 — classified as 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.
Reports received per month
Most reported problems
Device problems
- Separation Failure4
- Mechanical Problem2
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Information1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionNov 14, 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 20684710 ↗MalfunctionOct 11, 2024Separation Failure; Separation Failure
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20426175 ↗MalfunctionJun 9, 2023Mechanical Problem; Mechanical Problem
NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17100065 ↗MalfunctionJan 9, 2023Separation Failure; Separation Failure
IT WAS REPORTED THAT THE IMPLANT BODY AT TOOTH SITE #7 CANNOT BE REMOVED FROM THE FIXTURE MOUNT. THE IMPLANT WAS REMOVED, AND ANOTHER IMPLANT WAS PLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16125300 ↗MalfunctionOct 16, 2020Separation Failure; Separation Failure
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Information
MAUDE report 10692304 ↗
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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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