JuggerKnot CM-99629BRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00810020087352), received between Sep 22, 2022 and Mar 21, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING THE SURGERY, THE ANCHOR WAS NOT INSERTED INTO THE PATIENT'S BURR HOLE COMPLETELY (LITTLE BIT PROTRUDED) ALTHOUGH THE SURGEON IMPLANTED IT FOLLOWING THE NORMAL USAGE. SO, THE SURGEON PUSHED IN THE ANCHOR INTO THE PATIENT'S BURR HOLE AND FINISHED THE SURGERY WITH THE ANCHOR OF THE COMPLAINT PRODUCT. THE SAME INCIDENT OCCURRED ON 2 PRODUCTS. BY THE WAY, THE SURGEON IS FAMILIAR WITH THIS PRODUCT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18955024 ↗
• MalfunctionMar 21, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING THE SURGERY, THE ANCHOR WAS NOT INSERTED INTO THE PATIENT'S BURR HOLE COMPLETELY (LITTLE BIT PROTRUDED) ALTHOUGH THE SURGEON IMPLANTED IT FOLLOWING THE NORMAL USAGE. SO, THE SURGEON PUSHED IN THE ANCHOR INTO THE PATIENT'S BURR HOLE AND FINISHED THE SURGERY WITH THE ANCHOR OF THE COMPLAINT PRODUCT. THE SAME INCIDENT OCCURRED ON 2 PRODUCTS. BY THE WAY, THE SURGEON IS FAMILIAR WITH THIS PRODUCT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18954829 ↗
• MalfunctionMar 28, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING SURGERY, THE ANCHOR OF THIS COMPLAINT PRODUCT WAS PULLED OUT FROM THE PATIENT'S BURR HOLE UNINTENTIONALLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16628761 ↗
• MalfunctionSep 22, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ACCORDING TO THE REPORTER, "THE ANCHOR OF THIS COMPLAINT PRODUCT WAS PULLED OUT FROM THE PATIENT'S BUR HOLE ALTHOUGH THE SURGEON IMPLANTED THE ANCHOR ACCORDING TO THE NORMAL USAGE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15465973 ↗