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AESCULAP FW249RRecalls & reported problems

Aesculap AG · S4 ELEMENT LENKE PROBE CVD · Class 1

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 04046963743420), received between Sep 16, 2021 and Sep 16, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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

  • Fracture1

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.

  • MalfunctionSep 16, 2021Fracture; Fracture

    IT WAS REPORTED TO AESCULAP AG THAT A S4 ELEMENT LENKE PROBE CVD (PART # FW249R) WAS USED DURING A POSTERIOR LUMBAR INTERBODY FUSION ((PLIF) PROCEDURE PERFORMED ON (B)(6)2021. ACCORDING TO THE COMPLAINANT, DURING USE, THE WELD POINT AT BASE OF HANDLE BROKE LOOSE. THE AWL CRACKED BUT STAYED TOGETHER AS ONE PIECE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12484998 ↗

Other PROBE devices

All PROBE devices →

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