Click'X 498.571Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034791098), received between Jul 21, 2017 and May 2, 2019 — classified as 4 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS:IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION SURGERY INSTABILITY OF THE COLUMN SYSTEM. THE SURGEON MENTIONED THAT FOUR (4) CLICKX LOCKING CAPS WERE LOOSENED AND TWO (2) CLICKX 3D HEAD FOR PEDICLE SCREWS WERE DETACHED FROM THE SHANK OF THE SCREW CAUSING AN INSTABILITY OF THE FIXATION SYSTEM. AN X-RAY WAS TAKEN AND IT WAS SEEN THAT THE FOUR (4) CLICKX LOCKING CAP HAD LEFT THE SYSTEM AND TWO (2) CLICKX 3D HEAD FOR PEDICLE SCREW WERE THROWN OUT. THE WHOLE SYSTEM WAS REMOVED. INITIALLY, THE PATIENT UNDERWENT A LUMBAR CANAL SECONDARY L5 S1 RADICULOPATHY PLUS RELEASE PLUS RECALIBRATION WITH A TRANSPEDICULAR CLICK COLUMN SYSTEM ON (B)(6) 2019. IT WAS MENTIONED THAT THEY PLACED REVISION SCREW OR LARGER DIAMETER SCREWS TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS GOOD AND WELL. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS 2 OF 6 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 8575979 ↗
• InjuryMay 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN MEXICO AS FOLLOWS:IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION SURGERY INSTABILITY OF THE COLUMN SYSTEM. THE SURGEON MENTIONED THAT FOUR (4) CLICKX LOCKING CAPS WERE LOOSENED AND TWO (2) CLICKX 3D HEAD FOR PEDICLE SCREWS WERE DETACHED FROM THE SHANK OF THE SCREW CAUSING AN INSTABILITY OF THE FIXATION SYSTEM. AN X-RAY WAS TAKEN AND IT WAS SEEN THAT THE FOUR (4) CLICKX LOCKING CAP HAD LEFT THE SYSTEM AND TWO (2) CLICKX 3D HEAD FOR PEDICLE SCREW WERE THROWN OUT. THE WHOLE SYSTEM WAS REMOVED. INITIALLY, THE PATIENT UNDERWENT A LUMBAR CANAL SECONDARY L5 S1 RADICULOPATHY PLUS RELEASE PLUS RECALIBRATION WITH A TRANSPEDICULAR CLICK COLUMN SYSTEM ON (B)(6) 2019. IT WAS MENTIONED THAT THEY PLACED REVISION SCREW OR LARGER DIAMETER SCREWS TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS GOOD AND WELL. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS 1 OF 6 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 8575978 ↗
• InjuryJul 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS INITIALLY IMPLANTED WITH CLICKX SYSTEM AT L5 TO S1 IN (B)(6) 2005. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2006 FOR REVISION OF BROKEN SCREWS AT L5. PATIENT AGAIN RETURNED TO SURGERY ON (B)(6) 2015 FOR EXTENSION OF CONSTRUCT FROM L4 TO S1. DURING THAT PROCEDURE IT WAS NOTED ONE OF THE SCREWS AT S1 WAS "DEEPLY LODGED¿ IN PATIENT¿S ARTERY. IT WAS ALSO NOTED THAT A COMPETITOR'S INTERBODY DEVICE WAS ALSO IMPLANTED DURING THIS PROCEDURE. IT IS NOT KNOWN AT WHAT LEVEL. IN (B)(6) 2016, IT WAS NOTED THAT THE SCREW AT S1 THAT WAS REPORTED TO BE "DEEPLY LODGED¿ IN PATIENT¿S ARTERY HAD BENT. IT WAS FURTHER NOTED THE TWO (2) SCREWS AT L4 WERE BROKEN. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2016 WHERE SURGEON REMOVED ALL HARDWARE. PATIENT WAS REVISED TO A COMPETITOR'S CONSTRUCT. FOLLOWING THE (B)(6) 2016 PROCEDURE, PATIENT WAS HOSPITALIZED FOR SEVERAL DAYS. DURING THAT TIME PATIENT DEVELOPED AN INFECTION. PATIENT LATER DEVELOPED A FEVER WITHIN 24 HOURS OF DISCHARGE FROM THE HOSPITAL. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2016 WHERE SURGEON REMOVED ALL HARDWARE, CLEANED THE WOUND, AND ¿REINSTALLED THE SIX SCREWS.¿2006 REVISION IS ADDRESSED ON (B)(4). THE 2015 REVISION IS ADDR

  Patient problems: Unspecified Infection

  MAUDE report 6733724 ↗
• InjuryJul 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONCOMITANT DEVICE: CLICKX SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY: 1).

  Patient problems: Pain

  MAUDE report 6732250 ↗