Spline® Twist™ Implant System 2133Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024013308), received between Sep 21, 2022 and Sep 21, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanical Problem” (1 report).
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
Device problems
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2022Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT DR. INDICATED MALFUNCTION. WHILE PLACING THE IMPLANT, THE PHYSICIAN FELT THAT THE SCREW ON THE FIXTURE MOUNT WAS LOOSE, SO HE REMOVED THAT IMPLANT AND REINSERTED ANOTHER PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15461917 ↗
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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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