Speed-Lock 0747031550Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327054590), received between Dec 18, 2019 and Feb 16, 2022 — classified as 3 malfunctions.

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

• MalfunctionFeb 16, 2022Material Integrity Problem; Device Fell; Material Integrity Problem

  IT WAS REPORTED THAT A PIECE OF THE PRODUCT BECAME LOOSE AND FELL INSIDE THE PATIENT. THE PIECE OF THE PRODUCT REMAINED INSIDE THE PATIENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13544407 ↗
• MalfunctionDec 19, 2019Fluid/Blood Leak; Device Dislodged or Dislocated; Fluid/Blood Leak; Material Separation; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE O-RING CAME OFF AND WENT INTO THE PATIENT'S KNEE. THE O-RING WAS RETRIEVED AND PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9497619 ↗
• MalfunctionDec 18, 2019Fluid/Blood Leak; Device Dislodged or Dislocated; Fluid/Blood Leak; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE O-RING CAME OFF AND GOING INTO THE PATIENT'S KNEE. THE O-RING WAS RETRIEVED AND PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9492105 ↗