X-FUSE AXF-S0Recalls & reported problems
Stryker GmbH · Superelastic Implant · Class 2 · Implant
- 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 07613252258476), received between Sep 25, 2020 and Sep 25, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Fracture1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2020Fracture; Fracture
CUSTOMER REPORTED THE FOLLOWING: "DESCRIPTION OF THE FACTS: BROKEN IMPLANT; OBSERVED CLINICAL CONSEQUENCES: IMPLANT CHANGE".
Patient problems: Failure of Implant
MAUDE report 10586135 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.