Speed SE-2520Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00810633020234), received between Apr 5, 2016 and Oct 1, 2019 — classified as 1 injury, 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHEN CHECKING THE ORTHOKIT CCI BMW-SPEED SE-2520, A PACKAGED AND STILL UNOPENED CCI IMPLANT WAS DAMAGED. IT WAS THEN REMOVED FROM THE ORTHOKIT. THE CCI IMPLANT WAS NO LONGER PLACED ON THE INSERTION INSTRUMENT IN ITS UNOPENED PACKAGING AND WAS TRIGGERED AND NO LONGER READY FOR USE. THIS REPORT IS FOR ONE (1) SPEED COMPRESSION IMPLANT KIT 25 X 20 X 20 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9141279 ↗
• InjurySep 28, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A FOOT SURGERY ON (B)(6) 2018 WHEREIN THE SURGEON IMPLANTED TWO (2) SPEED COMPRESSION IMPLANT KIT. THE PATIENT WAS SEEN POST OPERATIVELY ON (B)(6) 2018 AND HAD AN X-RAY WHICH REVEALED ONE(1) STAPLE HAD A BROKEN LEG. NO ACTION TO BE TAKEN AS PER SURGEON'S ADVISED. THERE WAS NO SURGICAL DELAY AND PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME IS GOOD. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 7920855 ↗
• MalfunctionApr 5, 2016Break; Break

  ONE SPEED WAS INSERTED APPROPRIATELY DURING MED CUNEIFORM/NAVICULAR FUSION PROCEDURE DOS UNKNOWN. FOLLOW-UP X-RAY (B)(6) 2013 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 5548838 ↗
• MalfunctionApr 5, 2016Break; Break

  TWO SPEED (SAME SIZE AND SAME LOT) (SE-2520) WERE INSERTED APPROPRIATELY DURING CC FUSION PROCEDURE DOS UNKNOWN. FOLLOW-UP X-RAY (B)(6) 2013 REVEALED THAT BOTH IMPLANTS 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 5548812 ↗
• MalfunctionApr 5, 2016Break; Break

  TWO SPEED (SAME SIZE AND SAME LOT) (SE-2520) WERE INSERTED APPROPRIATELY DURING CC FUSION PROCEDURE DOS UNKNOWN. FOLLOW-UP X-RAY (B)(6) 2013 REVEALED THAT BOTH IMPLANTS 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 5548293 ↗