AESCULAP ST267TRecalls & reported problems
Aesculap AG · S4 ELEMENT POLYAXIAL SCREW 6.0X60MM · Class 2 · Implant
Data updated Oct 16, 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 04046963739300), received between Dec 3, 2021 and Dec 3, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Unintended System Motion” (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
- Unintended System Motion1
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.
InjuryDec 3, 2021Unintended System Motion; Unintended System Motion
IT WAS REPORTED TO AESCULAP AG THAT A S4 ELEMENT POLYAXIAL SCREW 6.0X60MM (PART # ST267T) WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SURGEON WANTED TO TURN HIS HEAD SO THAT IT WAS INSERTED INTO THE PATIENT AND THE SCREW "DISINTEGRATED;" THE INNER SEALING RING WAS LOOSENED. THE PATIENT WAS NOT DAMAGED, THE SURGEON HAD TO REMOVE THE SCREW AND USE A NEW ONE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12924032 ↗
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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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