VARIAX 628008Recalls & reported problems
Stryker GmbH · Superior Plate - Decreased Curvature · Class 2 · Implant
All models of VARIAX (345)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613252441885), received between Jan 17, 2019 and Sep 24, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 16, 2026.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Device Dislodged or Dislocated1
Patient problems
- Injury1
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 24, 2019Device Dislodged or Dislocated
AS REPORTED: "TREATED REVISION SURGERY DUE TO BACK OUT OF SCREWS. REPLACES PLATE THE SCREW."
Patient problems: Injury; No Known Impact Or Consequence To Patient
MAUDE report 9108826 ↗InjuryJan 17, 2019Appropriate Device Problem Term/Code Not Available
THE REASON FOR THE REVISION IS UNKNOWN HOWEVER THE PLATE AND ALL SEVEN SCREWS WERE REMOVED FROM THE PATIENT. THE PATIENT AND HER FAMILY DEMANDED TO HAVE THE IMPLANTS THEREFORE ARE NOT AVAILABLE FOR INVESTIGATION.
Patient problems: No Code Available
MAUDE report 8259048 ↗
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- PRECICE® Plating System LP4.5-DRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls1 report
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- PRECICE® Plating System LP4.5-PRT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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