Speed Titan SE-2520TIRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00810633021576), received between Apr 5, 2016 and May 21, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2025Break; Break

  IT WAS REPORTED THAT THE SURGEON WAS PREPARING TO IMPLANT THE PRODUCT IN QUESTION, BUT SHORTLY AFTER OPENING AND BEFORE APPLYING THE IMPLANT PROCEDURE, HE REALIZED THAT THE PLASTIC INSERTER WAS BROKEN AND DEFECTIVE, SO HE WAS UNABLE TO USE THE IMPLANT ON THE PATIENT. NEW DEVICE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22063126 ↗
• MalfunctionMar 4, 2024Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT ON (B)(6) 2023, THE INSERTION HANDLE WAS CRACKED WHEN THE IMPLANT WAS OPENED ONTO THE SURGICAL FIELD. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF 10 MINUTES. THEY HAD USED A DIFFERENT IMPLANT. THIS REPORT IS FOR ONE (1) SPEEDTITAN COMPRESSION IMPL KIT 25X20X20 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18828093 ↗
• MalfunctionFeb 20, 2024Break; Break

  DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A FOOT SURGERY ON (B)(6) 2024, THE PLACEMENT INSTRUMENT OF TWO SPEED TITAN COMPRESSION IMPLANT KITS BROKE OFF. THE DOCTOR HAD TO USE FORCEPS TO INSERT THE IMPLANTS. THE DEFECTIVE PLACEMENT INSTRUMENTS WERE THROWN AWAY. NO FRAGMENTS REMAINED IN THE PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO HARM TO PATIENT OR USER. NO ADDITIONAL SURGICAL INTERVENTION PLANNED. THIS REPORT IS FOR A SPEED TITAN COMPRESSION IMPL KIT 25X20X20. THIS IS REPORT 1 OF 2 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18743933 ↗
• MalfunctionAug 18, 2023Break; Break

  IT WAS REPORTED THAT DURING SURGERY ON (B)(4) 2023, THE INSERTION HANDLE OF A SPEEDTITAN CCI STAPLE IMPLANT KIT WAS FOUND TO BE BROKEN AFTER IT WAS OPENED FROM ITS STERILE PACKAGE. THE PRONGS OF THE STAPLE LOST THEIR LOADED TENSION AND IT DID NOT FIT IN THE DRILL HOLES FROM THE DRILL GUIDE INCLUDED WITH THE KIT. ANOTHER CCI STAPLE OF THE SAME TYPE WAS OPENED AND USED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY OR PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE SPEED TITAN 25X20X20MM IMPLANT KIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17572817 ↗
• MalfunctionApr 19, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SPAIN AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSERTION TOOL CONTAINING THE SPEEDTITAN IMPLANT WAS BROKEN DESPITE THE PACKAGING BEING CORRECT AND UNDAMAGED. THE DOCTOR ORDERED ANOTHER IMPLANT OF THE SAME PART AND LOT AND THE SAME EVENT WAS REPEATED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) SPEED TITAN 25X20X20MM IMPLANT KIT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16768695 ↗
• MalfunctionApr 19, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SPAIN AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSERTION TOOL CONTAINING THE SPEEDTITAN IMPLANT WAS BROKEN DESPITE THE PACKAGING BEING CORRECT AND UNDAMAGED. THE DOCTOR ORDERED ANOTHER IMPLANT OF THE SAME PART AND LOT AND THE SAME EVENT WAS REPEATED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) SPEED TITAN 25X20X20MM IMPLANT KIT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16768693 ↗
• MalfunctionMay 3, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING INVENTORY ON (B)(6) 2022, IT WAS OBSERVED THAT THE BME SPEEDTITAN SE-2520TI IMPLANT STICKER AND IMPLANT WERE IN A SPEEDTITAN SE-2020TI BOX. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT INVOLVES ONE(1) DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14270357 ↗
• MalfunctionApr 19, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT HAD BROKEN IMPLANTS. TALONAVICULAR SURGERY DONE IN (B)(6) 2020 AND TWO BME CCI SPEED TITAN IMPLANTS WAS IMPLANTED. FIRST IMPLANT FOUND TO BE BROKEN 6 WEEKS AFTER SURGERY, SECOND IMPLANT FOUND TO BE BROKEN 5 MONTHS AFTER SURGERY. DESPITE BROKEN IMPLANTS, SURGEON WAS SUGGESTED THAT THE PATIENT IS PAINLESS AND NO NEED REVISION OR REMOVAL SURGERY. THE PATIENT IS NOT EXPERIENCING ADVERSE SITUATION AND NO ADDITIONAL MEDICAL INTERVENTION REQUIRED. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) SPEEDTITAN(TM) IMPLANT KIT 25 X 20 MM. THIS REPORT IS 1 OF 2 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11686678 ↗
• MalfunctionJan 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A SPEEDTITAN IMPLANT KIT STAPLE WAS DEPLOYED IN THE BOX AND BROKE PLASTIC HOLDER. IT IS UNKNOWN WHEN AND WHERE THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE IS PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) SPEEDTITAN(TM) IMPLANT KIT 25 X 20 MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11253153 ↗
• MalfunctionJan 7, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE, THE SPEEDTITAN IMPLANT KIT WAS NOT LOADED ON THE INSERTER CORRECTLY AND CLOSED BEFORE IMPLANTATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE IS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) SPEEDTITAN(TM) IMPLANT KIT 25 X 20 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11136209 ↗
• MalfunctionApr 5, 2016Break; Break

  SPEED TITAN ((B)(4)) WAS INSERTED APPROPRIATELY DURING MIDFOOT PROCEDURE (B)(6) 2015. FOLLOW-UP X-RAY ON (B)(6) 2015 REVEALED THAT IMPLANT HAD BROKEN. PATIENT HAS NOT REQUIRED REVISION SURGERY, NOR REMOVAL OF BROKEN IMPLANT. IF ADDITIONAL INFORMATION PERTINENT TO THIS INCIDENT IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5548834 ↗