NA 6000-007-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04546540245052), received between Jun 26, 2018 and Jan 2, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Image Display Error/Artifact” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2024Incorrect Measurement; Unintended Movement; Incorrect Measurement; Unintended Movement

  PER THE CUSTOMER, THERE WAS MOVEMENT OF THE DEVICE AFTER LOCKING PLACE, WHICH COULD LEAD TO INACCURACIES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18425215 ↗
• MalfunctionAug 21, 2023Loose or Intermittent Connection; Incorrect Measurement; Loose or Intermittent Connection; Incorrect Measurement

  PER THE CUSTOMER, THE PART WHERE YOU PUT THE TRACKER ON IS LOOSE, NOT TIGHTENING. THIS COULD LEAD TO INACCURACIES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17582553 ↗
• MalfunctionApr 26, 2022Imprecision; Device Dislodged or Dislocated; Imprecision; Device Dislodged or Dislocated

  PER THE CUSTOMER, THE DEVICE BROKE AND WOULD NOT LOCK INTO PLACE DURING A CASE, THIS COULD POTENTIALLY CAUSE AND INACCURACY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14210582 ↗
• MalfunctionSep 3, 2019Image Display Error/Artifact; Component Missing; Image Display Error/Artifact; Component Missing

  IT WAS REPORTED THAT, DURING USE, IT WAS OBSERVED THAT A COMPONENT WAS LOOSE AND STILL INTACT WHICH COULD LEAD TO INACCURACIES. THERE WERE NO REPORTED ADVERSE CONSEQUENCES; THERE WERE NO SIGNIFICANT PROCEDURE DELAYS; THERE WAS NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8956759 ↗
• MalfunctionOct 3, 2018Image Display Error/Artifact; Image Display Error/Artifact

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE DEVICE IS NOT STAYING TIGHT, WHICH COULD LEAD TO INACCURACIES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME DEVICE WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7931312 ↗
• MalfunctionOct 2, 2018Image Display Error/Artifact; Image Display Error/Artifact

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE DEVICE IS NOT STAYING TIGHT, WHICH COULD LEAD TO INACCURACIES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME DEVICE WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7925896 ↗
• MalfunctionOct 2, 2018Break; Break

  IT WAS REPORTED THAT DURING THE SERVICE EVALUATION PROCESS CONDUCTED AT THE MANUFACTURER FACILITY IT WAS OBSERVED THAT THE SCREW WAS BROKEN OFF. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING THE SERVICE EVALUATION AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7925717 ↗
• MalfunctionSep 5, 2018Component Missing; Component Missing

  IT WAS REPORTED THAT DURING TESTING AT THE USER FACILITY A WASHER WAS FOUND MISSING ON THE DEVICE. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7847029 ↗
• MalfunctionJun 26, 2018Disassembly; Disassembly

  IT WAS REPORTED THAT PRIOR TO A SURGICAL PROCEDURE AT THE USER FACILITY A SCREW WAS FOUND MISSING ON THE DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7637461 ↗