Speed Shift SE-1520-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00810633020432), received between Dec 26, 2018 and May 22, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN DENMARK AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, DURING PRE-OP IT WAS NOTICED THAT THE PRODUCT HAS BROKEN IN THE BOX. THE PRODUCT HAS NOT BEEN OPENED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) SPEED SHIFT 15X20X20 OFFSET 8MM IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16975966 ↗
• MalfunctionMar 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN SPAIN AS FOLLOWS: IT WAS REPORTED THAT WHILE CHECKING THE DEPOSIT ON AN UNKNOWN DATE IN 2023 IT WAS DISCOVERED THAT THE IMPLANTS HAVE COME LOOSE FROM THE INSERTERS INSIDE THE UNOPENED CONTAINER. THERE IS ONLY ONE LOOSE. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) SPEEDSHIFT COMP IMPL KIT 15X20X20 OFST 8. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16478881 ↗
• 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. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SPEED SHIFT 15X20X20 OFFSET 8MM IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15896229 ↗
• MalfunctionMar 18, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, THE SPEED SHIFT COMPRESSION IMPLANT KIT STAPLES DISENGAGED FROM THE HANDLES. NO PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR (1) SPEEDSHIFT COMP IMPL KIT 15X20X20 OFST 8. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13803356 ↗
• MalfunctionMar 18, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, THE SPEED SHIFT COMPRESSION IMPLANT KIT STAPLES DISENGAGED FROM THE HANDLES. NO PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR (1) SPEEDSHIFT COMP IMPL KIT 15X20X20 OFST 8. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13803350 ↗
• MalfunctionAug 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM THE (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SALES REPRESENTATIVE RECEIVED SAMPLE PRODUCT WHERE IT APPEARED THAT THE CCI WAS COMPRESSED PRIOR TO THE PACK BEING OPENED. WHEN THE PACK WAS OPENED, THE INSERTION HANDLE FELL APART. THIS REPORT IS FOR A SPEED SHIFT 15X20X20X08MM IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12313666 ↗
• MalfunctionJul 19, 2021Detachment 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 (B)(6) 2021 THAT THE IMPLANT WAS LOOSE WITHIN THE SET, INSTEAD OF BEING ATTACHED TO THE HANDLE FOR INSERTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FIVE (5) MINUTE DELAY USING ANOTHER IMPLANT. THIS REPORT IS FOR ONE (1) SPEED SHIFT 15X20X20 OFFSET 8MM IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12191617 ↗
• MalfunctionMar 20, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON FEBRUARY 24, 2020, DURING A PRODUCT INVENTORY, A SPEED SHIFT HAD DEPLOYED INSIDE OF ITS BOX. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9862696 ↗
• MalfunctionDec 26, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SPEEDSHIFT COMPRESSION IMPLANT INSERTER CAME OFF INSIDE THE STERILE BOX. IT IS UNKNOWN WHEN WAS THE ISSUE DISCOVERED. PROCEDURE AND PATIENT INVOLVEMENT ARE UNKNOWN. THIS REPORT IS FOR A SPEED SHIFT COMPRESSION IMPLANT INSERTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8197385 ↗