AESCULAP ST266TRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046963739294), received between Dec 2, 2021 and Dec 2, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Unintended System Motion” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2021Unintended System Motion; Unintended System Motion

  IT WAS REPORTED TO AESCULAP AG THAT A S4 ELEMENT POLYAXIAL SCREW 6.0X55MM (PART # ST266T) WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE DEVICE DISINTEGRATED DURING SURGERY. DURING THE OPERATION, SURGEON WANTED TO TURN THE HEAD OF THE SCREW 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. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH REPORTS: 9610612-2021-00756 - 400526775, 9610612-2021-00758 - 400527068.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12920847 ↗
• InjuryDec 2, 2021Unintended System Motion; Unintended System Motion

  IT WAS REPORTED TO AESCULAP AG THAT A S4 ELEMENT POLYAXIAL SCREW 6.0X55MM (PART # ST266T) WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE DEVICE DISINTEGRATED DURING SURGERY. DURING THE OPERATION, SURGEON WANTED TO TURN THE HEAD OF THE SCREW 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. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH REPORTS: 9610612-2021-00756 - 400526775 AND 9610612-2021-00758 - 400527068.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12920769 ↗