VARIAX 628028SRecalls & 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 04546540686916), received between Jul 1, 2025 and Mar 30, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Insufficient Information1
- Nonunion/Delayed-union Bone Fracture1
- Osteolysis1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
AS REPORTED: "BONE RESORPTION FROM THE NONUNION WAS CONFIRMED".
Patient problems: Nonunion/Delayed-union Bone Fracture; Osteolysis
MAUDE report 24734304 ↗InjuryJul 1, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
AS REPORTED: "PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2025. TWO MONTHS AFTER SURGERY, AN X-RAY REVEALED THAT THE 2 LOCKING SCREWS INSERTED ON THE OUTSIDE PLATE HAD BACKED OUT OF THE PLATE AND THE LOCK HAD COME LOOSE. THE SCREWS INSERTED INTO THE FIRST AND THIRD HOLES FROM THE OUTER SIDE OF THE PLATE BACKED OUT. IT IS UNCLEAR WHICH OF THE SCREWS ACTUALLY BACKED OUT. THE PATIENT IS ORIGINALLY A FARMER AND, ACCORDING TO REPORTS, RESUMED WORK THREE WEEKS AFTER SURGERY WITHOUT FOLLOWING THE DOCTOR'S INSTRUCTIONS. REVISION SURGERY IS SCHEDULED ON (B)(6) 2025".
Patient problems: Insufficient Information
MAUDE report 22378035 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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