PathFinder NXT® 3505-6545Recalls & reported problems
Zimmer Spine, Inc. · Class 2
All models of PathFinder NXT (13)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00889024335707), received between Sep 2, 2020 and Aug 7, 2024 — classified as 14 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component7
- Fracture5
- Material Deformation2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- No Consequences Or Impact To Patient6
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT FOUR SEQUOIA CLOSURE TOPS STRIPPED INTRA-OPERATIVELY, AND IT WAS FOUND THAT THE TULIP HEAD OF THE BONE SCREW DISASSEMBLED FROM THE SHAFT. THE PROCEDURE WAS COMPLETED BY REPLACING THE IMPLANTS WITH ANOTHER CLOSURE TOP AND SCREW. THIS RESULTED IN A 30 MINUTE PROCEDURAL DELAY, BUT THERE WAS NO PATIENT IMPACT. THIS IS REPORT FIVE OF FIVE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19935086 ↗MalfunctionJun 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT FOUR SEQUOIA CLOSURE TOPS STRIPPED DURING FINAL TIGHTENING AND ONE PATHFINDER SCREW DISASSEMBLED DURING REMOVAL TO EXCHANGE IT FOR A LONGER SCREW INTRA-OPERATIVELY. THERE WAS A DELAY OF 30 MINUTES WITHOUT PATIENT IMPACTS. THIS IS REPORT FIVE OF FIVE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17133990 ↗MalfunctionOct 4, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT TWO PATHFINDER SCREWS DISASSEMBLED INTRA-OPERATIVELY DURING FINAL TIGHTENING. THEY WERE REMOVED WITHOUT PATIENT IMPACTS. THIS IS REPORT ONE OF TWO FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12568375 ↗MalfunctionOct 4, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT TWO PATHFINDER SCREWS DISASSEMBLED INTRA-OPERATIVELY DURING FINAL TIGHTENING. THEY WERE REMOVED WITHOUT PATIENT IMPACTS. THIS IS REPORT TWO OF TWO FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12568361 ↗MalfunctionJul 19, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING SURGERY, A CLOSURE TOP CROSS-THREADED INTO ITS MATING SCREW AND COULD NOT BE ADVANCED OR REMOVED. ADDITIONALLY, THREE SCREWS DISASSEMBLED. THE SCREWS WERE ALL REMOVED AND REPLACED, AND THE CLOSURE TOP WAS EVENTUALLY REMOVED AND REPLACED AFTER A DELAY TO THE PROCEDURE. THE PATIENT'S BONE WAS NOT DAMAGED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS IS REPORT THREE OF FOUR FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12188458 ↗MalfunctionJul 19, 2021Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation
IT WAS REPORTED THAT DURING SURGERY, A CLOSURE TOP CROSS-THREADED INTO ITS MATING SCREW AND COULD NOT BE ADVANCED OR REMOVED. ADDITIONALLY, THREE SCREWS DISASSEMBLED. THE SCREWS WERE ALL REMOVED AND REPLACED, AND THE CLOSURE TOP WAS EVENTUALLY REMOVED AND REPLACED AFTER A DELAY TO THE PROCEDURE. THE PATIENT'S BONE WAS NOT DAMAGED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS IS REPORT TWO OF FOUR FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12188456 ↗MalfunctionNov 4, 2020Material Deformation; Material Deformation
TWO PATHFINDER NXT CLOSURE TOPS AND SCREWS STRIPPED DURING TIGHTENING WITHIN SURGERY. THEY WERE REMOVED AND REPLACED WITH NEW SCREWS AND CLOSURE TOPS TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED PATIENT IMPACTS. THIS IS REPORT FOUR OF FOUR FOR THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10785914 ↗MalfunctionOct 19, 2020Fracture; Fracture
IT WAS REPORTED THAT TWO PATHFINDER NXT SCREWS FRACTURED IN-SITU WHEN TIGHTENING THE NUT. THE TWO SCREWS WERE REMOVED AND REPLACED. THERE WERE NO PATIENT IMPACTS. THIS IS REPORT ONE OF TWO.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10701618 ↗MalfunctionOct 19, 2020Fracture; Fracture
IT WAS REPORTED THAT TWO PATHFINDER NXT SCREWS FRACTURED IN-SITU WHEN TIGHTENING THE NUT. THE TWO SCREWS WERE REMOVED AND REPLACED. THERE WERE NO PATIENT IMPACTS. THIS IS REPORT TWO OF TWO.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10701549 ↗MalfunctionOct 14, 2020Break; Break
IT WAS REPORTED THAT DURING THE PROCEDURE THE SURGEON WANTED TO REVISE THE SCREW TO CHANGE THE TRAJECTORY. THE SCREW WAS REMOVED USING THE REMOVAL TOOL, BUT THEN BROKE AFTER IT WAS REMOVED FROM THE BODY. AN ALTERNATE SCREW OF THE SAME SIZE WAS USED TO COMPLETE THE CASE. THERE WERE NO REPORTED PATIENT IMPACTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10681545 ↗MalfunctionOct 5, 2020Fracture; Fracture
IT WAS REPORTED THREE PATHFINDER NXT SCREWS FRACTURED DURING SURGERY. ONE OF THE SCREWS BROKE IN THE SURGEON¿S HANDS WHILE ASSEMBLING. THE OTHER TWO SCREWS BROKE IN-SITU DURING THE TIGHTENING OF THE NUT. THE FRACTURED SCREWS WERE REMOVED AND REPLACED WITH NEW ONES. THERE WERE NO REPORTED PATIENT IMPACTS. THIS IS REPORT TWO OF THREE FOR THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10626625 ↗MalfunctionOct 5, 2020Fracture; Fracture
IT WAS REPORTED THREE PATHFINDER NXT SCREWS FRACTURED DURING SURGERY. ONE OF THE SCREWS BROKE IN THE SURGEON'S HANDS WHILE ASSEMBLING. THE OTHER TWO SCREWS BROKE IN-SITU DURING THE TIGHTENING OF THE NUT. THE FRACTURED SCREWS WERE REMOVED AND REPLACED WITH NEW ONES. THERE WERE NO REPORTED PATIENT IMPACTS. THIS IS REPORT THREE OF THREE FOR THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10626620 ↗MalfunctionOct 5, 2020Fracture; Fracture
IT WAS REPORTED THREE PATHFINDER NXT SCREWS FRACTURED DURING SURGERY. ONE OF THE SCREWS BROKE IN THE SURGEON'S HANDS WHILE ASSEMBLING. THE OTHER TWO SCREWS BROKE IN-SITU DURING THE TIGHTENING OF THE NUT. THE FRACTURED SCREWS WERE REMOVED AND REPLACED WITH NEW ONES. THERE WERE NO REPORTED PATIENT IMPACTS. THIS IS REPORT ONE OF THREE FOR THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10626613 ↗MalfunctionSep 2, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT AFTER FINAL TIGHTENING WAS COMPLETED, THE SURGEON DECIDED TO CHANGE THE TRAJECTORY OF THE SCREW AND REMOVED THE SCREW. ONCE THE PATHFINDER NXT SCREW WAS REMOVED AFTER FINAL TIGHTENING, THE HEAD UNLOCKED FROM THE SHAFT. THERE WAS NO ADVERSE EVENT. THERE WAS NO REPORTED PATIENT IMPACT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10483610 ↗
Other ORTHOSIS, SPINAL PEDICLE FIXATION devices
- NA 04.614.508Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION277 reports
- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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