Speed SE-1515Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810633020173), received between Jan 29, 2021 and May 21, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE STAPLE OF THE SPEED COMPRESSION IMPLANT KIT FELL OFF OF THE INSERTER WHILE STILL IN THE PACKAGING. THE ISSUE HAPPENED DURING SHIPPING WHILE AT THE OFFICE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) SPEED COMPRESSION IMPLANT KIT 15X15X15MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11866548 ↗
• MalfunctionJan 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING THE STOCK CHECK, IT WAS DISCOVERED THAT THE SPEED CCI PACKET¿S CCI IMPLANT HAD FALLEN OUT OF THE APPLICATOR. THE SPEED CCI PACKET CANNOT BE USED. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT INVOLVES ONE (1) SPEED 15X15X15MM IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11250536 ↗