Click'X 498.562Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034791029), received between Feb 19, 2020 and Feb 19, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Integrity Problem” (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. 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.

• InjuryFeb 19, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2009, THE PATIENT UNDERWENT A PEDICLE SCREW FIXATION L5 TO THE SACRUM BILATERALLY DUE TO SYMPTOMATIC DISK DERANGEMENT L5 WITH RADICULOPATHY BOTH LEGS. ON (B)(6) 2018, THE PATIENT WAS ADVISED FOR THE FIRST TIME THAT THE SOURCE OF HER CONTINUED PAIN WAS FRACTURES INVOLVING THE BILATERAL S1 PEDICLE SCREWS AS IDENTIFIED ON THE CT SCAN AND PLAIN FILMS OF THE LUMBAR SPINE. ON (B)(6) 2018, THE PATIENT WAS REQUIRED TO UNDERGO A PROCEDURE TO REMOVE THE HARDWARE/ FRACTURED PEDICLE SCREWS, HOWEVER, THE SURGEON WAS UNABLE TO REMOVE THE ROOTS OF THE SCREWS AND THEREFORE THE SCREWS REMAIN IN THE SACRUM. THIS REPORT IS FOR ONE (1) 6.2MM TI CLICK'X® PEDICLE SCR DUAL CORE 40MM THREAD LENGTH. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 9727560 ↗
• InjuryFeb 19, 2020Material Integrity Problem; Material Integrity Problem

  UNKNOWN SCREWS (PART NUMBER: UNKNOWN; LOT NUMBER: UNKNOWN; QUANTITY: 2), UNKNOWN RODS (PART NUMBER: UNKNOWN; LOT NUMBER: UNKNOWN; QUANTITY: 2).

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 9727559 ↗