JuggerKnot CM-99215Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00810020087246), received between Jun 22, 2022 and Jul 21, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2023Unintended Movement; Unintended Movement

  ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING THE SURGERY, THE SUTURE OF THIS COMPLAINT PRODUCT BECAME ABLE TO BE SLIDED AFTER THE SURGEON IMPLANTED THE ANCHOR INTO THE PATIENT'S BURR HOLE ALTHOUGH THIS COMPLAINT PRODUCT HAS NON-SLIDING SYSTEM. THE ABOVE INCIDENT OCCURRED, BUT THE ANCHOR OF THIS COMPLAINT PRODUCT WAS FIXED AND DIDN'T BE PULLED OUT FROM THE PATIENT'S BURR HOLE, SO THE SURGEON USED THIS COMPLAINT PRODUCT AS IS FOR THE SURGERY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17375313 ↗
• MalfunctionJul 21, 2023Unintended Movement; Unintended Movement

  ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING THE SURGERY, THE SUTURE OF THIS COMPLAINT PRODUCT BECAME ABLE TO BE SLIDED AFTER THE SURGEON IMPLANTED THE ANCHOR INTO THE PATIENT'S BURR HOLE ALTHOUGH THIS COMPLAINT PRODUCT HAS NON-SLIDING SYSTEM. THE ABOVE INCIDENT OCCURRED, BUT THE ANCHOR OF THIS COMPLAINT PRODUCT WAS FIXED AND DIDN'T BE PULLED OUT FROM THE PATIENT'S BURR HOLE, SO THE SURGEON USED THIS COMPLAINT PRODUCT AS IS FOR THE SURGERY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17375243 ↗
• MalfunctionMay 8, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING THE SURGERY, THE ANCHOR WAS PULLED OUT ALTHOUGH THE SURGEON IMPLANTED IT FOLLOWING THE NORMAL USAGE. THEREFORE, THE SURGEON USED A BACK UP PRODUCT FOR THE SURGERY. THE SAME INCIDENT OCCURRED ON THE 2 PRODUCTS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16888441 ↗
• MalfunctionMay 8, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING THE SURGERY, THE ANCHOR WAS PULLED OUT ALTHOUGH THE SURGEON IMPLANTED IT FOLLOWING THE NORMAL USAGE. THEREFORE, THE SURGEON USED A BACK UP PRODUCT FOR THE SURGERY. THE SAME INCIDENT OCCURRED ON THE 2 PRODUCTS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16888344 ↗
• MalfunctionJun 22, 2022Unintended Movement; Unintended Movement

  ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING SURGERY, THE SUTURE OF THIS COMPLAINT PRODUCT BECAME ABLE TO SLIDE WHEN THE SURGEON APPLIED TENSION TO THE SUTURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14779856 ↗