CONCORDE® ProTi 360°™ 188827107Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00819917021103), received between Jul 28, 2020 and Aug 7, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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.

• MalfunctionAug 7, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED FROM COMPLAINANT: IT WAS REPORTED THAT THIS WAS A POSTERIOR FUSION (L3/4/5) AND PLIF (L4/5) PERFORMED ON (B)(6), 2024. AFTER THE SURGERY, THE PSEUDOARTHROSIS DUE TO BONE FUSION FAILURE WAS CONFIRMED. THE REMOVAL SURGERY FOR INTERVERTEBRAL CAGE IN QUESTION AND POSTERIOR SCREW IN QUESTION WAS PERFORMED ON (B)(6), 2024. IN THE SURGERY, AFTER THE CAGE WAS REMOVED, THE PROTI CONCORDE 0° 9X7X27 WAS FOUND TO BE DAMAGED. THE FRAGMENT WAS IN THE BONE GRAFT SPACE OF THE CAGE AND NO INTERNAL REMAINS WERE OBSERVED. THE CAUSE IS UNKNOWN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. FURTHER ADDITIONAL INFORMATION RESPONSE FROM COMPLAINANT: - LOT NUMBER - NO FURTHER INFORMATION IS AVAILABLE. - ANY IMAGING RELATED TO THE (B)(6) 2024 ORIGINAL SURGERY. - NO FURTHER INFORMATION IS AVAILABLE. - ANY IMAGING RELATED TO THE (B)(6) 2024 REMOVAL SURGERY. - NO FURTHER INFORMATION IS AVAILABLE. - WAS THE DEVICE NOTICED TO BE DAMAGED DURING THE ORIGINAL SURGERY OR ON IMAGING? - IT WAS NOTICED DURING THE SECOND SURGERY. - WILL THE DEVICE BE MADE AVAILABLE FOR RETURN? - NO FURTHER INFORMATION IS AVAILABLE. - PATIENT DETAILS - AGE, HEIGHT, WEIGHT

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 19931540 ↗
• InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SALES REP WAS CONTACTED BY SURGEON'S OFFICE STAFF ON 9/27/2023 REQUESTING THE METAL COMPOSITION FOR IMPLANTS USED ON A PATIENT. THE REP EMAILED THE SURGEON AND HIS STAFF DIRECTLY AFTER BEING CONTACTED. HE PROVIDED THEM WITH THE REQUESTED INFORMATION FOR DEPUY EXPEDIUM AND LEGACY SYNTHES- METAL COMPOSITION BREAKDOWNS. THEY SAID THE PATIENT WAS EXPERIENCING SWELLING, REDNESS AND IRRITATION IN HIS ABDOMEN. POTENTIALLY MAY BE HAVING A REACTION TO THE IMPLANTS. HE WAS CONTACTED AGAIN BY SURGEON'S OFFICE THIS AFTERNOON. THE PATIENT WAS REFERRED TO A DERMATOLOGIST AND SURGEON'S OFFICE ASKED IF WE COULD PROVIDE "PATCH TEST KIT". THIS COMPLAINT INVOLVES FOUR (4) DEVICES. ONLY 1 DEVICE OUT OF THE 4 REPORTED IS MADE BY TYBER MEDICAL.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18049605 ↗
• InjuryJul 28, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  "ON (B)(6) 2020, MIS-TLIF WAS PERFORMED IN L2/3. THE PROCEDURE WAS DELAYED MORE THAN 30 MINUTES. ON (B)(6) 2020, THE SURGEON REPORTED THAT A REMOVAL PROCEDURE WOULD BE HELD BECAUSE THE PATIENT'S INFECTION WAS SUSPECTED. ON (B)(6) 2020, THE PROCEDURE WAS PERFORMED TO REMOVE THE CONCORDE DEVICE(S) AND TRANSPLANT THE ILIUM. THERE WAS NO NOTABLE DAMAGE OR PEELING OF THE COATING ON THE DEVICE IN QUESTION. NO FURTHER INFORMATION IS AVAILABLE."

  Patient problems: Unspecified Infection

  MAUDE report 10334023 ↗