XIA II 03820101Recalls & reported problems
Stryker Corporation · OFFSET CONNECTOR · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540148742), received between Oct 25, 2016 and Apr 19, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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
- Break2
- Fracture1
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 19, 2018Fracture; Break; Fracture
IT WAS REPORTED THAT DURING A REVISION SURGERY TO HARVEST AUTOGENOUS BONE AND TO DO ANTERIOR OPERATION, THE OFFSET CONNECTOR WAS BROKEN WHEN TIGHTENING. THE OFFSET CONNECTOR WAS REPLACED WITH A NEW ONE AND THE SURGERY WAS COMPLETED. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7444967 ↗MalfunctionOct 25, 2016Break
IT WAS REPORTED THAT DURING SURGERY, THE SURGEON USED THE OFFSET CONNECTOR. HE TIGHTENED THE SCREW OF THE OFFSET CONNECTOR. THE SCREW WAS BROKEN. THEREFORE, THE SURGEON CHANGED THE OFFSET CONNECTOR TO BRAND NEW PRODUCT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6055203 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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