NA 397.084Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034778495), received between Nov 21, 2019 and Nov 21, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical Jam” (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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2019Mechanical Jam; Mechanical Jam

  THE RETENTION LEVER ON THE INSTRUMENT DOES NOT WORK PROPERLY AND DOESN'T ALLOW THE DISTRACTOR TO STAY LOCKED IN THE DISTRACTED POSITION. SURGERY WAS COMPLETED WITHOUT THE LATERAL DISTRACTOR. A LAMINAR SPREADER WAS USED INSTEAD WHICH IS ALSO INCLUDED IN THE SAME SET. NO CONSEQUENCE TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9355040 ↗