Speed SE-1818Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00810633020197), received between Apr 5, 2016 and Jul 1, 2020 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, ONE STAPLE HAS COME OFF THE INSERTER TOOL AND RENDERING IT USELESS. IT WAS UNKNOWN HOW IT HAPPENED AND WHEN IT WAS DISCOVERED. THERE WAS NO SURGERY AND PATIENT INVOLVEMENT REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) SPEED COMPRESSION IMPLANT KIT 18X18X18MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10221135 ↗
• MalfunctionMar 26, 2020Detachment 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 DURING A LEFT MIDFOOT FUSION WITH A REPAIR OF PERONEAL TENDON WITH BONE GRAFT, THE COMPRESSION IMPLANT HAD LOOSENED FROM INSERTION HANDLE DURING TRANSPORT AND FULLY DETACHED WHILE THE BOX WAS BEING OPENED. THE IMPLANT WAS UNABLE TO BE INSERTED AS COMPRESSION HAD ALREADY INITIATED UPON RELEASE FROM HANDLE, MEANING IT WOULD NO LONGER MATCH UP TO THE PRE-DRILLED HOLES. PATIENT STATUS AND SURGICAL DELAY WAS UNKNOWN. THIS IS REPORT 1 OF 1 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9884436 ↗
• MalfunctionAug 11, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IN (B)(6) 2013, TWO SPEED IMPLANTS (SE-0907) WERE INSERTED. DURING TWO WEEK POST OPERATIVE VISIT, PATIENT COMPLAINED OF PAIN AND X-RAY REVEALED THAT IMPLANTS WERE BACKING OUT OF BONE. REVISION SURGERY TOOK PLACE IN (B)(6) 2013 AND BOTH IMPLANTS WERE REMOVED, USING ANOTHER UNKNOWN DEVICE FOR FINAL FIXATION. IF ADDITIONAL INFORMATION PERTINENT TO THIS INCIDENT IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Pain

  MAUDE report 5868275 ↗
• MalfunctionAug 11, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IN (B)(6) 2013, TWO SPEED IMPLANTS (SE-0907) WERE INSERTED. DURING TWO WEEK POST OPERATIVE VISIT, PATIENT COMPLAINED OF PAIN AND X-RAY REVEALED THAT IMPLANTS WERE BACKING OUT OF BONE. REVISION SURGERY TOOK PLACE IN (B)(6) 2013 AND BOTH IMPLANTS WERE REMOVED, USING ANOTHER UNKNOWN DEVICE FOR FINAL FIXATION. IF ADDITIONAL INFORMATION PERTINENT TO THIS INCIDENT IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Pain

  MAUDE report 5868264 ↗
• MalfunctionApr 26, 2016Break; Break

  TWO SPEED IMPLANTS (SE-1818, SE-1515) WERE INSERTED APPROPRIATELY DURING LIS FRANC PROCEDURE (B)(6) 2015. ON OR AROUND (B)(6) 2016, BROKEN IMPLANTS WERE REMOVED. 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 5609512 ↗
• MalfunctionApr 26, 2016Break; Break

  TWO SPEED IMPLANTS (SE-1818, SE-1515) WERE INSERTED APPROPRIATELY DURING LIS FRANC PROCEDURE (B)(6) 2015. ON OR AROUND (B)(6) 2016, BROKEN IMPLANTS WERE REMOVED. 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 5607974 ↗
• MalfunctionApr 5, 2016Break; Break

  SPEED (SE-1818) WAS INSERTED APPROPRIATELY DURING TRIPLE PROCEDURE (B)(6) 2013. FOLLOW-UP X-RAY ON (B)(6) 2014 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 5549406 ↗
• MalfunctionApr 5, 2016Break; Break

  SPEED (SE-1818) WAS INSERTED APPROPRIATELY DURING TN FUSION PROCEDURE (B)(6) 2015. FOLLOW-UP X-RAY (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 5548362 ↗