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AESCULAP ME586RRecalls & reported problems

Aesculap, Inc. · 8.5 MM DETACHABLE TRIAL INSTRUMENT · Class 1

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 04046964920523), received between May 5, 2021 and May 5, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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

  • Device-Device Incompatibility1

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.

  • InjuryMay 5, 2021Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A DETACHABLE TRIAL INSTRUMENT. ACCORDING TO THE COMPLAINT DESCRIPTION, THE TRIAL WAS NOTED TO BE LOOSE ON THE 8.5 MM SPACER. THE PROCEDURE WAS AN ANTERIOR DISC REPLACEMENT (ADR). THE TRIAL FELL INTO THE WOUND AND WAS IMMEDIATELY RETRIEVED; IT WAS USED AGAIN IN THE SURGERY. THERE WAS A DELAY OF LESS THAN 30 SECONDS. THE DEVICE WILL BE AVAILABLE FOR RETURN TO THE MANUFACTURER. THE ADVERSE EVENT IS FILED UNDER REFERENCE XC (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11778879 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.