Speed Shift SE-1520-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00810633020449), received between Jan 17, 2019 and Dec 1, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE STAPLES WERE OFF THE INSERTER. THIS REPORT INVOLVES ONE SPEED SHIFT 15X20X20 OFFSET 10MM IMPLANT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15896314 ↗
• MalfunctionMay 12, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WERE TWO BROKEN SCREWS IN THE UK LOAN SET WHEN THE PACK WAS OPENED. THIS REPORT INVOLVES ONE (1) SPEED SHIFT 15X20X20 OFFSET 10MM IMPLANT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11813024 ↗
• MalfunctionMay 12, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WERE TWO BROKEN SCREWS IN THE UK LOAN SET WHEN THE PACK WAS OPENED. THIS REPORT INVOLVES ONE (1) SPEED SHIFT 15X20X20 OFFSET 10MM IMPLANT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11812947 ↗
• MalfunctionSep 16, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON FEBRUARY 10, 2020 THAT THE CUSTOMER RECEIVED A BROKEN PRODUCT. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) SPEEDSHIFT(TM) IMPLANT KIT 15 X 20 MM, OFFSET 10 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10542063 ↗
• MalfunctionJun 9, 2020Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  UPDATED CONCOMITANT DEVICE REPORTED: UNK - INSERTION HANDLE (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10132965 ↗
• MalfunctionJan 17, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHILE PREPARING FOR AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, THE SALES CONSULTANT DISCOVERED THAT TWO (2) 6MM SPEEDSHIFT COMPRESSION IMPLANT KITS AND ONE (1) 10MM SPEEDSHIFT COMPRESSION IMPLANT KIT HAD COME OFF THE INSERTER INSIDE THE STERILE PACKAGE. IT IS UNKNOWN WHEN WAS THE ISSUE DISCOVERED. THERE IS NO REPORTED PATIENT CONSEQUENCE. PROCEDURE OUTCOME IS UNKNOWN. THIS REPORT IS FOR A SPEEDSHIFT COMPRESSION IMPLANT KIT 15X20X20MM OFFSET 10MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8256598 ↗