Click'X 498.989Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034792385), received between Aug 9, 2018 and May 7, 2019 — classified as 2 injuries, 1 malfunction.

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

  THIS IS REPORT 5 OF 10 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 8587583 ↗
• 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 8587444 ↗
• MalfunctionAug 9, 2018Detachment of Device or Device Component; Material Twisted/Bent; Detachment of Device or Device Component; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A LUMBAR ARTHRODESIS PROCEDURE. THE CLICK X PEDICLE SCREW DUSTED THE THREAD IN THE FINAL TIGHTENING. DURING THE PROCEDURE THERE WAS LOSS OF THE THREAD OF 2 PEDICLE SCREWS, MAKING THE SURGICAL PROCEDURE DIFFICULT. IT WAS NECESSARY TO USE PRESSURE TO REMOVE THE SCREW. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO PATIENT OUTCOME REPORTED. DURING MANUFACTURER¿S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE LOCKING HEAD PORTION OF THE IMPLANT FELL APART IN ADDITION THERE IS DAMAGE TO THE TOP OF THE SCREW PORTION (MOSTLY LIKELY DONE BY PLIERS TO REMOVE THE SCREW, AS MATERIAL IS BENT AND ROLLED OVER) AND THE TOP PROXIMAL THREADS SHOWINGS SIGNS OF ROLLING. THIS DEVICE CONDITION WAS RE-EVALUATED AND DETERMINED TO BE REPORTABLE ON (B)(6) 2018. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7769953 ↗