NA 03.816.340Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034731049), received between Oct 15, 2021 and Jan 18, 2023 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionJan 18, 2023Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: INSIGHT LATERAL ACCESS SET (B)(4). LOAN SET EQUIPMENT NUMBER: 3000130098. SERIAL: (B)(4). THIS SET HAD SEVERAL ISSUES. THE BLADE ON THE DISC ANC BL F/THIIRD BLADE HOLD L140 03.816.340 DID NOT STAY WITHIN THE BLADE UNTIL THE INSTRUMENT WAS USED ON IT. THE HOLDING BLADE APPEARED NOT TO BE ABLE TO REMAIN IN THE RETRACTION BLADE. THIS WAS AN ISSUE AS IT TOOK AWAY CONTROL FROM THE SURGEON AND CREATED AN EXTRA ITEM TO FOR CONSIDERATION. WE WENT AHEAD WITH THE CASE AND THE DR WORKED WITH THE SET. THE BLADE DOES NOT SIT FLUSH IN THE BLADE HOLDER WHICH SITS ON THE RETRACTOR BODY. WE USED A MALLET SO THAT IT WOULD BE STABLE ENOUGH FOR RETRACTION. SAME CODE DISC ANC BL F/THIIRD BLADE HOLD L140 03.816.340. THERE WAS SURGICAL DELAY FOR ABOUT 4 TO 5 MINUTES. THE SURGERY WAS SUCCESSFULLY COMPLETED. THE PATIENT APPEARED TO BE UNAFFECTED BY THIS ISSUE. THIS REPORT IS FOR ONE (1) DISC ANCH BL F/THIRD BLADE HOLD L140. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16193721 ↗
• 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 (1) DISC ANCH BL F/THIRD BLADE HOLD L140. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12731905 ↗
• 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 140MM FOR 3RD BLADE HOLDER. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12641930 ↗