NA 6000-999-003Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04546540391919), received between Aug 21, 2018 and May 12, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  PER THE CUSTOMER THE FITTING PART WAS DAMAGED WHICH COULD LEAD TO DIS ASSEMBLY DURING A PROCEDURE. 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 16920921 ↗
• MalfunctionOct 22, 2019Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING SET UP IT WAS OBSERVED THAT THE WASHER WAS BROKEN AND MISSING FROM THE DEVICE; THIS POSES THE RISK OF A SMALL COMPONENT BEING LOST IN THE SURGICAL SITE. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING SETUP AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 9221176 ↗
• MalfunctionJul 3, 2019Break; Break

  IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MANUFACTURER FACILITY IT WAS FOUND THAT A PART OF THE TIGHTENING SCREW IS BROKEN OFF AND THE BROKEN PART IS MISSING, POSING THE RISK OF A SMALL COMPONENT BEING LOST IN THE SURGICAL SITE. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MANUFACTURING FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8757823 ↗
• MalfunctionJun 27, 2019Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING TESTING, IT WAS OBSERVED THAT THE LOCKING MECHANISM IS MISSING; THIS POSES THE RISK OF A SMALL COMPONENT BEING LOST IN THE SURGICAL SITE. . 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 Patient Involvement

  MAUDE report 8741568 ↗
• MalfunctionOct 3, 2018Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO A SURGICAL PROCEDURE AT THE USER FACILITY THE TOP CAME OFF THE DEVICE. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING 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 7931297 ↗
• MalfunctionAug 21, 2018Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A PELVIC ACETABULAR OSTEOTOMY NAVIGATION PROCEDURE, A NAVLOCK CLAMP ATTACHED TO THE OSTEOTOME WAS IMPACTED WITH A HAMMER AND A WASHER ON THE NAVLOCK BROKE INTO THREE PIECES. THE SURGEON WAS ABLE TO REMOVE THE FRAGMENTS ENSURING NO REMAINING FRAGMENTS WERE LEFT IN THE PATIENT. 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 7800870 ↗