NA 498.141Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034789019), received between May 7, 2019 and May 8, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 8, 2019Migration; Migration

  06/18/2019: UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN ELECTIVE REVISION SURGERY SYSTEM INSTABILITY DUE TO THE CLICK COLUMN SYSTEM HAD LOOSENED, SPECIFICALLY, THE 3D HEADS, LOCKING SCREWS AND FOUR (4) PEDICLE SCREWS. THE PATIENT PRESENTED PAIN BEFORE DETECTING THE MALFUNCTION. THE CLICK COLUMN SYSTEM MALFUNCTION WAS DETECTED EARLY MARCH 2019. IT WAS MENTIONED THAT THE SCREWS THAT WERE USED IN THE SURGERY WERE PRE-ASSEMBLED FROM CLICK COLUMN SYSTEM THAT IS TO SAY THAT IN THIS SURGERY THEY DID NOT USE THE 3D HEADS. THE DEVICES WERE ORIGINALLY IMPLANTED ON (B)(6) 2019. THE RECOVERED IMPLANTS WERE, TWO (2) CLICKX PRE-ASSEMBLED SCREWS 6.2 X 45, TWO (2) CLICKX PRE-ASSEMBLED SCREWS 6.2 X 50, TWO (2) SOFT CURVED RODS AND FOUR (4) CLICKX LOCKING CAPS. THE SURGEON WILL MONITOR THE EFFECTIVENESS OF THE CLICK COLUMN SYSTEM THROUGH POSTOPERATIVE RADIOGRAPHIC CONTROLS. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CURRENTLY, THE PATIENT WAS IN GOOD CONDITION. THIS COMPLAINT INVOLVES TEN (10) DEVICES.

  Patient problems: Pain

  MAUDE report 8591225 ↗
• InjuryMay 7, 2019Unintended Movement; Unintended Movement

  06/18/2019: UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN ELECTIVE REVISION SURGERY SYSTEM INSTABILITY DUE TO THE CLICK COLUMN SYSTEM HAD LOOSENED, SPECIFICALLY, THE 3D HEADS, LOCKING SCREWS AND FOUR (4) PEDICLE SCREWS. THE PATIENT PRESENTED PAIN BEFORE DETECTING THE MALFUNCTION. THE CLICK COLUMN SYSTEM MALFUNCTION WAS DETECTED EARLY (B)(6) 2019. IT WAS MENTIONED THAT THE SCREWS THAT WERE USED IN THE SURGERY WERE PRE-ASSEMBLED FROM CLICK COLUMN SYSTEM THAT IS TO SAY THAT IN THIS SURGERY THEY DID NOT USE THE 3D HEADS. THE DEVICES WERE ORIGINALLY IMPLANTED ON (B)(6) 2019. THE RECOVERED IMPLANTS WERE, TWO (2) CLICKX PRE-ASSEMBLED SCREWS 6.2 X 45, TWO (2) CLICKX PRE-ASSEMBLED SCREWS 6.2 X 50, TWO (2) SOFT CURVED RODS AND FOUR (4) CLICKX LOCKING CAPS. THE SURGEON WILL MONITOR THE EFFECTIVENESS OF THE CLICK COLUMN SYSTEM THROUGH POSTOPERATIVE RADIOGRAPHIC CONTROLS. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CURRENTLY, THE PATIENT WAS IN GOOD CONDITION. THIS COMPLAINT INVOLVES TEN (10) DEVICES.

  Patient problems: No Code Available; Pain

  MAUDE report 8587547 ↗