Click'X 498.990Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034792392), received between Jun 11, 2018 and May 7, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Unintended Movement” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2019Unintended Movement; Unintended Movement

  ON 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 (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 8587641 ↗
• InjuryMay 7, 2019Unintended Movement; Unintended Movement

  ON 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 (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 8587489 ↗
• InjuryJun 11, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2018 TO REMOVE THE 6.2MM PREASSEMBLED CLICKX PEDICLE SCREW DUE TO THE RELEASE OF THE 3D HEAD OF THE SCREW. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) 6.2MM CLICKX PEDICLE SCREW PREASSEMBLED 50MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 7589717 ↗