NA 163005530Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034507378), received between Jun 14, 2018 and Mar 27, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN MEXICO AS FOLLOWS: IT WAS REPORTED THAT WHEN USED IN A PATIENT, IN DISC SPACE L4 L5, DURING SUCTION, IT WAS CONNECTED TO THE ASPIRATION TO PROCEED TO THE EXTRACTION OF THE NUCLEUS PULPOSUS DISK, IT WAS BROKEN IN THE VISOR OF THE UNION OF THE DIAMETERS OF THE PRODUCT. HOWEVER, IT COULD BE STILL USED IN SURGERY. THERE WERE NO OPERATIVE COMPLICATIONS OR RISK TO THE PATIENT. WE DO NOT HAVE THE DEVICE SINCE HAVING BEEN IN CONTACT WITH A PATIENT, THE DEVICE IS CONSIDERED CONTAMINATED AND MUST BE REMOVED BY BIOLOGICAL CONTROLS. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9892098 ↗
• MalfunctionDec 2, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT UNDERWENT A POSTERIOR LUMBAR INTERBODY FUSION (PLIF) PROCEDURE TO TREAT THE LUMBAR SPINAL CANAL STENOSIS (L4-5) ON (B)(6) 2019. DURING THE PROCEDURE THE SURGEON REMOVED DEGENERATED DISC WITH THE CONCORDE CLEAR 30 DEGREES IN QUESTION FROM THE RIGHT SIDE (SURGEON¿S SIDE) WITHOUT ISSUE. NEXT, THE SURGEON INSERTED IT FROM THE LEFT SIDE (SURGEON¿S SIDE). WHEN SURGEON STARTED DISC REMOVAL, IT BROKE WHERE THE TUBING¿S DIAMETER BECOMES LARGER TO 8MM (80MM FROM THE TIP GUARD). IT WAS CONFIRMED BY POSTOPERATIVE X-RAYS THAT NO FRAGMENT WAS LEFT IN THE PATIENT¿S BODY. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT'S OUTCOME IS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9396474 ↗
• MalfunctionDec 19, 2018Break; Break

  IT WAS REPORTED THAT THE CONCORDE CLEAR TIP BROKE OFF. PATIENT CONSEQUENCE? :NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8180811 ↗
• MalfunctionJun 14, 2018Break; Break

  WHEN INTRODUCING THE DEVICE IN DISC SPACE, PERFORMING DISCECTOMY, IN A USUAL MANEUVER, THE DEVICE BROKE. I HAVE PHOTOS AND VIDEO! PATIENT CONSEQUENCE?: NO. ACTION TAKEN FOR PROCEDURE: PERFORMED THE REST OF PROCEDURE WITH TYPICAL INSTRUMENTS. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT?: YES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7602744 ↗