NA 03.612.014Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034714516), received between Jan 29, 2020 and Jan 29, 2020 — classified as 1 malfunction.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionJan 29, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON WAS PERFORMING AN MINIMALLY INVASIVE (MIS) DECOMPRESSION SURGERY AND WHEN USING THE ADAPTOR FOR THE BLADE RETRACTOR, SURGEON FOUND THAT THE ADAPTOR WAS NOT PROPERLY HOLDING TO THE MIS FLEX ARM, WHERE THE SCREW WAS LIKELY STRIPPED. SURGEON SIMPLY USED THE OTHER ADAPTOR FROM THE SET AND CONTINUED HIS CASE WITHOUT ANY DELAY. THERE WAS NO PATIENT IMPACT. PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9644871 ↗