NA 498.140Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034789002), received between May 10, 2019 and May 10, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 10, 2019Break; Break

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A PROCEDURE TO REMOVE BROKEN IMPLANTS. THE DEVICES WERE IMPLANTED YEARS AGO. THE PATIENT REPORTEDLY EXPERIENCED A LOT OF PAIN AND UNDERWENT MANY TREATMENTS SUCH AS INFILTRATIONS AND BLOCKAGES AS WELL AS RADIOFREQUENCY FOR PAIN, BUT THE CAUSE OF THE PAIN WAS NEVER FOUND. IT WAS DECIDED TO OPERATE TO SEE IF ANYTHING IN SITU COULD BE THE CAUSE OF THE PAIN. A BROKEN CLICKX ROD AT THE HEIGHT OF THE MIDDLE SCREW ON THE RIGHT SIDE AND A BROKEN CLICKX LOCKING CAP OF THE UPPER SCREW WERE DISCOVERED. THERE WERE FRAGMENTS GENERATED FROM THE BROKEN DEVICE AND THEY WERE REMOVED EASILY. THE CLICKX ROD AND THE CLICKX LOCKING CAP TO WERE CHANGED TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT STATUS WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: SCREW (PART/LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR A CLICKX ROD. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant; Pain

  MAUDE report 8601440 ↗