AESCULAP SW378TRecalls & reported problems
Aesculap AG · S4 POLYAXIAL SCREW 8.5X55MM CANULATED · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046963319328), received between Feb 2, 2018 and Feb 2, 2018 — classified as 1 malfunction.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- 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.
MalfunctionFeb 2, 2018Break; Break
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH S4 POLYAXIAL SCREW 8.5X55MM CANULATED. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE SCREW DETACHED INTO TWO PARTS. THE SCREW COULD NOT BE REMOVED FROM THE BONE, WAS ONLY ABLE TO BE REMOVED WITH A SCREWDRIVER. THERE HAD BEEN A 8-10 MINUTES OP TIME EXTENSION, THE RESULT WAS SUCCESSFUL AND THERE WAS NO PATIENT HARM. THE COMPLAINT DEVICES ARE AVAILABLE TO BE RETURN TO THE MANUFACTURER FOR EVALUATION. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 7238455 ↗
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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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