VARIAX 629664Recalls & reported problems
Stryker GmbH · Profile Plate, 2.4 · Class 2 · Implant
All models of VARIAX (345)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327398625), received between Aug 31, 2023 and Aug 31, 2023 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "PATIENT HAD REMOVAL OF INFECTED HARDWARE AND PLACED ON AN EXTERNAL FIXATOR". ADDITIONAL INFORMATION RECEIVED FROM SALES REP: THE PATIENT HAD AN EXTERNAL FIXATOR PLACED FOLLOWING A SEVERE FRACTURE. FOLLOWING THE CONTINUATION OF THEIR TREATMENT, THE PATIENT HAD THE EXTERNAL FIXATOR REMOVED AND 3 PLATES (1 AXSOS, 1 PROFILE, AND 1 VARIAX) AND 19 SCREWS (10 AXSOS, 2 PROFILE, AND 7 VARIAX) INSERTED. ULTIMATELY, THE PATIENT HAD REVISION SURGERY TO REMOVE THE PLATES AND SCREWS DUE TO INFECTION. FOLLOWING THE REMOVAL OF THE PLATES AND SCREWS, THE PATIENT WAS GIVEN AN LRF CIRCULAR EXTERNAL FIXATOR.
Patient problems: Unspecified Infection
MAUDE report 17661644 ↗
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- PRECICE® Plating System LP4.5-DRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls1 report
- PRECICE® Plating System LP4.5-PLF40Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
- 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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