AXSOS 627456SRecalls & reported problems
Stryker GmbH · Distal Anterolateral Tibia Plate · Class 2 · Implant
All models of AXSOS (184)
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 07613327082012), received between May 21, 2018 and May 29, 2018 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (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
- Break1
Patient problems
- No Code Available1
- Rupture1
- Ulceration1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 29, 2018Appropriate Device Problem Term/Code Not Available
THE SURGEON REPORTED THAT HE WAS REVISING A PATIENT WHO HAD BEEN IMPLANTED WITH AN AXSOS 3 PLATE TO FIX A FRACTURED LEFT TIBIA BECAUSE THE DISTAL MEDAL PART OF THE AXSOS 3 PLATE WAS SITTING OFF THE BONE AND WAS STICKING THROUGH THE PATIENT'S SKIN ON THE MEDIAL SIDE CAUSING ULCERATION OF THE SKIN. THE SURGEON FURTHER REPORTED THAT THE PLATE HAD CAUSED RUPTURE OF THE TENDON. THE SURGEON DID COMMENT THAT HE THOUGHT IF THE MOST MEDIAL DISTAL HOLE HAS BEEN FILLED THIS EVENT MAY HAVE BEEN AVERTED.
Patient problems: Rupture; Ulceration
MAUDE report 7548347 ↗InjuryMay 21, 2018Break
THREE WEEKS AFTER SURGERY IS COMPLETELY UNLOADED. A LOAD OF 1/3 THEREFROM, 1/2 LOAD AFTER 1 MONTH AFTER THE OPERATION, AND A STAGE, THE TOTAL LOAD IN 5 WEEKS AFTER OPERATION. THE PLATE HAD BROKEN BASED ON X-RAY , THE PATIENT LEAVE THE HOSPITAL 3.5 MONTHS AFTER SURGERY .
Patient problems: No Code Available
MAUDE report 7531075 ↗
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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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