Speed Shift SE-1520-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00810633020425), received between Jan 17, 2019 and Feb 6, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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.

• MalfunctionFeb 6, 2023Crack; Crack

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS NOTICED THAT THE INSERTER WAS CRACKED WHEN RESTOCKING THE SPEED SHIFT TOTE. THERE WAS NO CONSEQUENCE TO A PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SPEED SHIFT 15X20X20 OFFSET 6MM IMPLANT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16308679 ↗
• MalfunctionFeb 6, 2023Crack; Crack

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS NOTICED THAT THE INSERTER WAS CRACKED WHEN RESTOCKING THE SPEED SHIFT TOTE. THERE WAS NO CONSEQUENCE TO A PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SPEED SHIFT 15X20X20 OFFSET 6MM IMPLANT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16308675 ↗
• MalfunctionMar 1, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE SPEEDSHIFT IMPLANT KIT WAS FOUND BROKEN INSIDE THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) SPEEDSHIFT COMPRESSION IMPLANT KIT 15X20MM OFFSET 6MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13637607 ↗
• MalfunctionNov 13, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING 2020 AUDIT, THE SPEED SHIFT IMPLANT KIT WAS FOUND TO BE INEFFECTIVE. IT WAS OBSERVED THAT THE COMPRESSION STAPLE FELL OUT OF ITS INSERTER. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR 1 SPEEDSHIFT(TM) IMPLANT KIT 15 X 15 MM, OFFSET 6 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10839588 ↗
• MalfunctionJan 17, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2018, THE SPEEDSHIFT COMPRESSION IMPLANT KIT WAS RECEIVED WITH THE SPEEDSHIFT IMPLANT NO LONGER CONNECTED TO ITS INSERTION HANDLE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SPEEDSHIFT COMPRESSION IMPLANT KIT 15X20MM OFFSET 6MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9601408 ↗
• MalfunctionDec 11, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  FURTHER IT WAS REPORTED THAT IT WAS CALCANEAL OSTEOTOMY PROCEDURE. THE PACKAGE OF THE IMPLANT KIT WAS STILL SEALED BEFORE IT WAS OPENED.

  Patient problems: No Patient Involvement

  MAUDE report 9455715 ↗
• 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 15X20MM OFFSET 6MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8256643 ↗
• 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 15X20MM OFFSET 6MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8256621 ↗