Speed Shift SE-2020-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810633020470), received between Sep 4, 2018 and Feb 22, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionFeb 22, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE SCRUB STAFF WAS PREPARING FOR AN UNKNOWN PROCEDURE, WHEN IT WAS NOTICED THAT THE IMPLANT HAD COME APART WHERE A SECTION OF THE HOLDER WAS BROKEN. THE PACKAGE WAS STILL INTACT AND THERE WAS NO SIGN OF VISIBLE DAMAGE. THERE WAS NO REPORTED PROCEDURE OR PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SPEED SHIFT 20X20X20X06MM IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8363014 ↗
• MalfunctionSep 4, 2018Break; Packaging Problem; Break; Packaging Problem

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A CASE ON (B)(6) 2018, THE CUSTOMER FOUND THAT ONE OF THE STAPLES IN THE SEALED BOX WAS BROKEN. THIS REPORT IS FOR ONE (1) SPEEDSHIFT COMPRESSION IMPLANT KIT 20X20X20MM OFFSET 6MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7843584 ↗