SynFrame 387.397Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034771267), received between Jun 6, 2022 and Jun 6, 2022 — classified as 1 malfunction.

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

• MalfunctionJun 6, 2022Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2022. WHEN THE RETRACTOR IN QUESTION WAS ATTACHED TO AN ARM, THE ENTIRE UNIT BECAME WOBBLY. WHEN A REPLACING RETRACTOR WAS ATTACHED TO THE SAME ARM, THE UNIT WORKED FINE. THE PROCEDURE WAS COMPLETED LESS THAN 30 MINUTES. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE SYNFRAME SOFT TISSUE RETRAC W/23 L180. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14601293 ↗