AXSOS 627510Recalls & reported problems
Stryker GmbH · Locking Compression Plate · Class 2 · Implant
All models of AXSOS (184)
Data updated Oct 18, 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 07613327173833), received between Jan 7, 2021 and Jan 7, 2021 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Fracture1
Patient problems
- Failure of Implant1
- Implant Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 7, 2021Fracture; Fracture
THE CUSTOMER SAID : " OPERATION ON (B)(6) 2020 OF A DISPLACED FRACTURE OF THE TWO BONES OF THE RIGHT LEG WITH A TIBIAL AXOS PLATE. LEG SUPPORT AUTHORIZED AT 2 MONTHS POST-OP ON (B)(6) 2020. SATISFACTORY X-RAY CLINICAL CHECK-UP ON (B)(6) 2020. RETURNS ON (B)(6) 2020 FOR PAIN. CONSEQUENCES : BROKEN TIBIAL PLATE AT 4 MONTHS, NO POST-OP INFECTIOUS SIGNS. REMOVAL OF THE PLATE AND SCREWS INCLUDING 4 LOCKED SCREWS. OSTEOSYNTHESIS AFTER BONE HARVESTING. ENDOMEDULLARY BY PLATE SCREWS ON THE TIBIA AND FIBULA, RESIN PLASTER."
Patient problems: Failure of Implant; Implant Pain
MAUDE report 11136241 ↗
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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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