Click'XRecalls & reported problems across all models
Synthes GmbH · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls
- 0
We found 4 models of Click'X by Synthes GmbH in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Nov 15, 2017 and Aug 2, 2022 — classified as 8 injuries, 12 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported Click'X problems
Device problems
- Unintended Movement7
- Fitting Problem5
- Material Integrity Problem3
- Break2
- Device-Device Incompatibility2
- Peeled/Delaminated1
Patient problems
- No Code Available7
- No Known Impact Or Consequence To Patient6
- Pain5
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient2
- Failure of Implant1
- No Patient Involvement1
Click'X models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Click'X 498.570APPLIANCE, FIXATION, SPINAL INTERLAMINAL15 reports
- Click'X 388.353TRAY, SURGICAL, INSTRUMENT2 reports
- Click'X 388.354SCREWDRIVER2 reports
- Click'X 388.365SCREWDRIVER1 report
Recent Click'X adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 2, 2022Material Integrity Problem; Material Integrity Problem
DEVICE REPORT FROM THE NETHERLANDS REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT (B)(6) 2022, THE EXTRACTION PLIERS WERE DISCOVERED TO BE CORRODED AND A PIECE WAS BROKEN OFF. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THIS REPORT IS FOR AN EXTRACTION PLIERS FOR CLICK'X. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15149893 ↗MalfunctionJan 31, 2022Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED ON (B)(6) 2022, THE EXTRACTION PLIERS WAS FOUND TO BE BROKEN DURING THE PREOP INSPECTION. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) EXTRACTION PLIERS FOR CLICK'X. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13402639 ↗MalfunctionNov 19, 2021Material Integrity Problem; Material Integrity Problem
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, PART OF THE SCREWDRIVER WAS BENT. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) SCREWDRIVER FOR TI CLICK'X® LOCKING CAP. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12845135 ↗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
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
MalfunctionAug 21, 2018Break; Break
DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT REMOVAL SURGERY TO REMOVE LOCKING NUTS AND RODS. DURING THE SURGERY, THE SURGEON NOTED THAT THE END OF ONE LOCKING CAP SCREWDRIVER WAS BENT AND DID NOT ENGAGE WELL. ADDITIONALLY, A PIECE OF THE SECOND SCREWDRIVER WAS SNAPPED OFF. IT IS UNKNOWN WHEN THIS OCCURRED. PATIENT WAS EXAMINED FOR METAL AND X-RAYS WERE DONE. NO TRACE OF METAL FOUND. THE PROCEDURE WAS PROLONGED FOR UNKNOWN LENGTH OF TIME WHILE ATTEMPTING TO UNLOCK THE LOCKING CAP. PROCEDURE WAS COMPLETED. PATIENT OUTCOME WAS NOT REPORTED. THIS REPORT IS FOR ONE (1) SCREWDRIVER FOR TI CLICK'X® LOCKING CAP. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7801015 ↗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 ↗
Other Synthes GmbH products
All Synthes GmbH devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page