Click'X 498.570Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10705034791081), received between Jan 16, 2018 and Oct 16, 2019 — classified as 8 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (7 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryOct 16, 2019Unintended Movement; Unintended Movement

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A LEVEL S1 LUMBAR ARTHRODESIS REVISION SURGERY DUE TO IMPLANT FAILURE. IT WAS DETERMINED ON AN UNKNOWN DATE THAT ALL THE LOCKING CAPS AND BARS HAD BECAME LOOSE FROM THE ORIGINAL OPERATION. THIS INCLUDED FIVE (5) CLICKX LOCKING CAPS, THREE (3) 3.5 MM CLICKX LOCKING CAPS, EIGHT (8) UNKNOWN CLICKX SCREWS AND TWO (2) UNKNOWN BARS. THERE WAS A SURGICAL DELAY OF FIFTEEN (15) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT WAS STABLE. THIS IS REPORT 8 OF 10 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4) AND IS RELATED TO THE INTRAOPERATIVE EVENT CAPTURED IN (B)(4).

  Patient problems: No Code Available

  MAUDE report 9197919 ↗
• InjuryOct 16, 2019Unintended Movement; Unintended Movement

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A LEVEL S1 LUMBAR ARTHRODESIS REVISION SURGERY DUE TO IMPLANT FAILURE. IT WAS DETERMINED ON AN UNKNOWN DATE THAT ALL THE LOCKING CAPS AND BARS HAD BECAME LOOSE FROM THE ORIGINAL OPERATION. THIS INCLUDED FIVE (5) CLICKX LOCKING CAPS, THREE (3) 3.5 MM CLICKX LOCKING CAPS, EIGHT (8) UNKNOWN CLICKX SCREWS AND TWO (2) UNKNOWN BARS. THERE WAS A SURGICAL DELAY OF FIFTEEN (15) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT WAS STABLE. (B)(4).

  Patient problems: No Code Available

  MAUDE report 9197823 ↗
• InjuryOct 16, 2019Unintended Movement; Unintended Movement

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A LEVEL S1 LUMBAR ARTHRODESIS REVISION SURGERY DUE TO IMPLANT FAILURE. IT WAS DETERMINED ON AN UNKNOWN DATE THAT ALL THE LOCKING CAPS AND BARS HAD BECAME LOOSE FROM THE ORIGINAL OPERATION. THIS INCLUDED FIVE (5) CLICKX LOCKING CAPS, THREE (3) 3.5MM CLICKX LOCKING CAPS, EIGHT (8) UNKNOWN CLICKX SCREWS AND TWO (2) UNKNOWN BARS. THERE WAS A SURGICAL DELAY OF FIFTEEN (15) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT WAS STABLE. THIS IS REPORT 6 OF 10 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4) AND IS RELATED TO THE INTRAOPERATIVE EVENT CAPTURED IN (B)(4).

  Patient problems: No Code Available

  MAUDE report 9197759 ↗
• MalfunctionOct 15, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A LUMBAR ARTHRODESIS PROCEDURE THE SURGEON WAS UNABLE TO ADJUST THE TWO (2) LOCKING CAPS AND COULD NOT INSERT THE TWO (2) CROSS-LINK CLAMPS. THE PATIENT STATUS IS STABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), SCREWDRIVER SHAFT 3.5 WITH HEXAGONAL QUICK COUPLING 6.0MM FOR CLICK X (PART # 388.079, LOT # UNKNOWN, QUANTITY 1), SCREWDRIVER SHAFT 3.5 MM LONG WITH HEXAGONAL QUICK COUPLING 6.0 M, FOR CLICK X (PART # 388.329, LOT # UNKNOWN, QUANTITY 1), CLICKX LOCK CAP (PART # 498.570, LOT # UNKNOWN, QUANTITY 1), CLICKX LOCK CAP (PART # 04.606.000, LOT # UNKNOWN, QUANTITY 5). THIS REPORT IS FOR ONE (1) CLICKX LOCKCAP F/498.571 TAN. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9193125 ↗
• MalfunctionOct 15, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A LUMBAR ARTHRODESIS PROCEDURE THE SURGEON WAS UNABLE TO ADJUST THE TWO (2) LOCKING CAPS AND COULD NOT INSERT THE TWO (2) CROSS-LINK CLAMPS. THE PATIENT STATUS IS STABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). SCREWDRIVER SHAFT 3.5 WITH HEXAGONAL QUICK COUPLING 6.0MM FOR CLICK X (PART # 388.079, LOT # UNKNOWN, QUANTITY 1). SCREWDRIVER SHAFT 3.5 MM LONG WITH HEXAGONAL QUICK COUPLING 6.0 M, FOR CLICK X (PART # 388.329, LOT # UNKNOWN, QUANTITY 1). CLICKX LOCK CAP (PART # 498.570, LOT # UNKNOWN, QUANTITY 1). CLICKX LOCK CAP (PART # 04.606.000, LOT # UNKNOWN, QUANTITY 5). THIS REPORT IS FOR ONE (1) CLICKX LOCKCAP F/498.571 TAN. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9193078 ↗
• InjuryMay 10, 2019Break; Break

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A PROCEDURE TO REMOVE BROKEN IMPLANTS. THE DEVICES WERE IMPLANTED YEARS AGO. THE PATIENT REPORTEDLY EXPERIENCED A LOT OF PAIN AND UNDERWENT MANY TREATMENTS SUCH AS INFILTRATIONS AND BLOCKAGES AS WELL AS RADIOFREQUENCY FOR PAIN, BUT THE CAUSE OF THE PAIN WAS NEVER FOUND. IT WAS DECIDED TO OPERATE TO SEE IF ANYTHING IN SITU COULD BE THE CAUSE OF THE PAIN. A BROKEN CLICKX ROD AT THE HEIGHT OF THE MIDDLE SCREW ON THE RIGHT SIDE AND A BROKEN CLICKX LOCKING CAP OF THE UPPER SCREW WERE DISCOVERED. THERE WERE FRAGMENTS GENERATED FROM THE BROKEN DEVICE AND THEY WERE REMOVED EASILY. THE CLICKX ROD AND THE CLICKX LOCKING CAP TO WERE CHANGED TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT STATUS WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: SCREW (PART/LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR A CLICKX LOCKING CAP. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant; Pain

  MAUDE report 8601454 ↗
• InjuryMay 7, 2019Unintended Movement; Unintended Movement

  (B)(6) 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 (B)(4) DEVICES.

  Patient problems: No Code Available; Pain

  MAUDE report 8587797 ↗
• InjuryMay 7, 2019Unintended Movement; Unintended Movement

  THIS IS REPORT 8 OF 10 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 8587790 ↗
• 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 8587706 ↗
• InjuryMay 7, 2019Unintended Movement; Unintended Movement

  THIS IS REPORT 2 OF 10 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 8587446 ↗
• MalfunctionJan 16, 2018Fitting Problem; Fitting Problem

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A SURGERY PERFORMED ON (B)(6) 2017, THE SURGEON NOTED THAT THE SCREWDRIVER AVAILABLE FOR USE WOULD NOT WORK WITH THE CLICK´X SYSTEM + T-PAL IMPLANTS BEING PLACED IN A PATIENT. REPORTEDLY, THE PATIENT WAS ANESTHETIZED AND AS THE SURGEON PROCEEDED TO PLACE THE SIX CLICK´X SCREWS HE HAD TO FORCE THE SCREWDRIVER SO THAT THE FIRST SCREW WAS PLACED CORRECTLY AND LOCKED WITH THE CORRESPONDING CLICK X LOCKING CAP. THE SCREWDRIVER DID NOT WORK AT ALL AND THE SURGEON WAS UNABLE TO CORRECTLY SECURE THE OTHER FIVE CLICK X LOCKING CAPS. ADDITIONALLY REPORTED, THE SURGEON RECEIVED WITH THE SET, TWO STRAIGHT RODS AND NOT TWO CURVED RODS AS EXPECTED. AS SUCH, HE HAD TO MANUALLY ADAPT THE BAR TO FIT THE CONSTRUCT. THE SURGEON COMPLETED THE SURGERY BUT ONLY ONE LOCKING CAP WAS FIT AS EXPECTED, THE OTHER FIVE DID NOT FIT (NOR DID THE DEVICES MAKE THE CLICK SOUND AS EXPECTED), THE SURGEON TRIED TO FIT AS MUCH AS SCREWDRIVER ALLOWED. THE SURGERY WAS DELAYED BY 45 MINUTES DUE TO THE INTRA-OPERATIVE EVENTS. THE PATIENT WAS REPORTEDLY DISCHARGED FROM THE CLINIC AND IS UNDER PERIODIC SUPERVISION. THERE HAVE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7196430 ↗
• MalfunctionJan 16, 2018Fitting Problem; Fitting Problem

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A SURGERY PERFORMED ON (B)(6) 2017, THE SURGEON NOTED THAT THE SCREWDRIVER AVAILABLE FOR USE WOULD NOT WORK WITH THE CLICK´X SYSTEM + T-PAL IMPLANTS BEING PLACED IN A PATIENT. REPORTEDLY, THE PATIENT WAS ANESTHETIZED AND AS THE SURGEON PROCEEDED TO PLACE THE SIX CLICK´X SCREWS HE HAD TO FORCE THE SCREWDRIVER SO THAT THE FIRST SCREW WAS PLACED CORRECTLY AND LOCKED WITH THE CORRESPONDING CLICK X LOCKING CAP. THE SCREWDRIVER DID NOT WORK AT ALL AND THE SURGEON WAS UNABLE TO CORRECTLY SECURE THE OTHER FIVE CLICK X LOCKING CAPS. ADDITIONALLY REPORTED, THE SURGEON RECEIVED WITH THE SET, TWO STRAIGHT RODS AND NOT TWO CURVED RODS AS EXPECTED. AS SUCH, HE HAD TO MANUALLY ADAPT THE BAR TO FIT THE CONSTRUCT. THE SURGEON COMPLETED THE SURGERY BUT ONLY ONE LOCKING CAP WAS FIT AS EXPECTED, THE OTHER FIVE DID NOT FIT (NOR DID THE DEVICES MAKE THE CLICK SOUND AS EXPECTED), THE SURGEON TRIED TO FIT AS MUCH AS SCREWDRIVER ALLOWED. THE SURGERY WAS DELAYED BY 45 MINUTES DUE TO THE INTRA-OPERATIVE EVENTS. THE PATIENT WAS REPORTEDLY DISCHARGED FROM THE CLINIC AND IS UNDER PERIODIC SUPERVISION. THERE HAVE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7196403 ↗
• MalfunctionJan 16, 2018Fitting Problem; Fitting Problem

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A SURGERY PERFORMED ON (B)(6) 2017, THE SURGEON NOTED THAT THE SCREWDRIVER AVAILABLE FOR USE WOULD NOT WORK WITH THE CLICK´X SYSTEM + T-PAL IMPLANTS BEING PLACED IN A PATIENT. REPORTEDLY, THE PATIENT WAS ANESTHETIZED AND AS THE SURGEON PROCEEDED TO PLACE THE SIX CLICK´X SCREWS HE HAD TO FORCE THE SCREWDRIVER SO THAT THE FIRST SCREW WAS PLACED CORRECTLY AND LOCKED WITH THE CORRESPONDING CLICK X LOCKING CAP. THE SCREWDRIVER DID NOT WORK AT ALL AND THE SURGEON WAS UNABLE TO CORRECTLY SECURE THE OTHER FIVE CLICK X LOCKING CAPS. ADDITIONALLY REPORTED, THE SURGEON RECEIVED WITH THE SET, TWO STRAIGHT RODS AND NOT TWO CURVED RODS AS EXPECTED. AS SUCH, HE HAD TO MANUALLY ADAPT THE BAR TO FIT THE CONSTRUCT. THE SURGEON COMPLETED THE SURGERY BUT ONLY ONE LOCKING CAP WAS FIT AS EXPECTED, THE OTHER FIVE DID NOT FIT (NOR DID THE DEVICES MAKE THE CLICK SOUND AS EXPECTED), THE SURGEON TRIED TO FIT AS MUCH AS SCREWDRIVER ALLOWED. THE SURGERY WAS DELAYED BY 45 MINUTES DUE TO THE INTRA-OPERATIVE EVENTS. THE PATIENT WAS REPORTEDLY DISCHARGED FROM THE CLINIC AND IS UNDER PERIODIC SUPERVISION. THERE HAVE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7196400 ↗
• MalfunctionJan 16, 2018Fitting Problem; Fitting Problem

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A SURGERY PERFORMED ON (B)(6) 2017, THE SURGEON NOTED THAT THE SCREWDRIVER AVAILABLE FOR USE WOULD NOT WORK WITH THE CLICK´X SYSTEM + T-PAL IMPLANTS BEING PLACED IN A PATIENT. REPORTEDLY, THE PATIENT WAS ANESTHETIZED AND AS THE SURGEON PROCEEDED TO PLACE THE SIX CLICK´X SCREWS HE HAD TO FORCE THE SCREWDRIVER SO THAT THE FIRST SCREW WAS PLACED CORRECTLY AND LOCKED WITH THE CORRESPONDING CLICK X LOCKING CAP. THE SCREWDRIVER DID NOT WORK AT ALL AND THE SURGEON WAS UNABLE TO CORRECTLY SECURE THE OTHER FIVE CLICK X LOCKING CAPS. ADDITIONALLY REPORTED, THE SURGEON RECEIVED WITH THE SET, TWO STRAIGHT RODS AND NOT TWO CURVED RODS AS EXPECTED. AS SUCH, HE HAD TO MANUALLY ADAPT THE BAR TO FIT THE CONSTRUCT. THE SURGEON COMPLETED THE SURGERY BUT ONLY ONE LOCKING CAP WAS FIT AS EXPECTED, THE OTHER FIVE DID NOT FIT (NOR DID THE DEVICES MAKE THE CLICK SOUND AS EXPECTED), THE SURGEON TRIED TO FIT AS MUCH AS SCREWDRIVER ALLOWED. THE SURGERY WAS DELAYED BY 45 MINUTES DUE TO THE INTRA-OPERATIVE EVENTS. THE PATIENT WAS REPORTEDLY DISCHARGED FROM THE CLINIC AND IS UNDER PERIODIC SUPERVISION. THERE HAVE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7196397 ↗
• MalfunctionJan 16, 2018Fitting Problem; Fitting Problem

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A SURGERY PERFORMED ON (B)(6) 2017, THE SURGEON NOTED THAT THE SCREWDRIVER AVAILABLE FOR USE WOULD NOT WORK WITH THE CLICK´X SYSTEM + T-PAL IMPLANTS BEING PLACED IN A PATIENT. REPORTEDLY, THE PATIENT WAS ANESTHETIZED AND AS THE SURGEON PROCEEDED TO PLACE THE SIX CLICK´X SCREWS HE HAD TO FORCE THE SCREWDRIVER SO THAT THE FIRST SCREW WAS PLACED CORRECTLY AND LOCKED WITH THE CORRESPONDING CLICK X LOCKING CAP. THE SCREWDRIVER DID NOT WORK AT ALL AND THE SURGEON WAS UNABLE TO CORRECTLY SECURE THE OTHER FIVE CLICK X LOCKING CAPS. ADDITIONALLY REPORTED, THE SURGEON RECEIVED WITH THE SET, TWO STRAIGHT RODS AND NOT TWO CURVED RODS AS EXPECTED. AS SUCH, HE HAD TO MANUALLY ADAPT THE BAR TO FIT THE CONSTRUCT. THE SURGEON COMPLETED THE SURGERY BUT ONLY ONE LOCKING CAP WAS FIT AS EXPECTED, THE OTHER FIVE DID NOT FIT (NOR DID THE DEVICES MAKE THE CLICK SOUND AS EXPECTED), THE SURGEON TRIED TO FIT AS MUCH AS SCREWDRIVER ALLOWED. THE SURGERY WAS DELAYED BY 45 MINUTES DUE TO THE INTRA-OPERATIVE EVENTS. THE PATIENT WAS REPORTEDLY DISCHARGED FROM THE CLINIC AND IS UNDER PERIODIC SUPERVISION. THERE HAVE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7196385 ↗