NA 03.816.300Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034731001), received between Oct 15, 2021 and Sep 30, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Compatibility Problem” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Compatibility Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951452 ↗
• MalfunctionNov 1, 2021Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THAT THE BLADE WOULD NOT LOCK INTO PLACE AND COULD FALL OUT. THE ITEM IS NEW AND THE ORIGINAL PACKAGING HAS ONLY BEEN OPENED. THIS REPORT IS FOR ONE (1) DISC ANCH BL F/THIRD BLADE HOLD L100. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12731919 ↗
• MalfunctionOct 15, 2021Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, DURING THE ROUTINE INSPECTION OF THE LOAN SET IN THE WAREHOUSE THE BLADE DOES NOT LOCK INTO PLACE AND CAN FALL OUT. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DISC ANCHOR BLADE 100MM FOR 3RD BLADE HOLDER. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12641920 ↗