ARCADIUS® XP L SO893PRecalls & reported problems
Aesculap AG · ARCADIUS XP L IMPLANT 14° 29X40X18MM · Class 2 · Implant
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 04046964043918), received between Sep 27, 2021 and Sep 27, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Crack” (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
- Crack1
- Fracture1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 27, 2021Crack; Fracture; Crack; Fracture
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH SO878P: ARCADIUS XP L IMPLANT 14° 25X35X18MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE IMPLANT CRACKED. AFTER FULLY SEATING THE IMPLANT, TWO SCREWS WERE SUCCESSFULLY IMPLANTED IN THE TOP HOLES. A THIRD WAS INSERTED IN THE BOTTOM LEFT (LOOKING DOWN AT THE PATIENT) HOLE. THE IMPLANT CRACKED ON THE FRONT FACE UPON FINAL TIGHTENING OF THIS SCREW, SO THE DOCTOR OPTED TO REMOVE AND REPLACE THE SPACER. NO ADDITIONAL INTERVENTION WAS REQUIRED TO RETRIEVE THE DEVICE BEYOND NORMAL RETRIEVAL PROCEDURE, AS THE DEVICE STAYED IN ONE PIECE. THERE WAS A SIGNIFICANT SURGERY DELAY. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12535901 ↗
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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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