PathFinder NXTRecalls & reported problems across all models
Zimmer Spine, Inc. · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 35
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 13 models of PathFinder NXT by Zimmer Spine, Inc. in the FDA's device registry (GUDID). Together they are named in 35 adverse event reports in the FDA's MAUDE database, received between Sep 2, 2020 and Jul 10, 2026 — classified as 1 injury, 34 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (13 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
Reports received per month, all models
Most reported PathFinder NXT problems
Device problems
- Detachment of Device or Device Component13
- Fracture13
- Material Deformation4
- Break3
- Crack1
- Device Markings/Labelling Problem1
- Packaging Problem1
- Wrong Label1
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- No Consequences Or Impact To Patient6
- No Known Impact Or Consequence To Patient5
- Insufficient Information3
- Foreign Body In Patient1
PathFinder NXT models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PathFinder NXT® 3505-6545ORTHOSIS, SPINAL PEDICLE FIXATION14 reports
- PathFinder NXT® 3505-6540ORTHOSIS, SPINAL PEDICLE FIXATION4 reports
- PathFinder NXT® 3558-1ORTHOSIS, SPINAL PEDICLE FIXATION3 reports
- PathFinder NXT® 3505-6550Orthosis, spondylolisthesis spinal fixation2 reports
- PathFinder NXT® 3505-7540ORTHOSIS, SPINAL PEDICLE FIXATION2 reports
- PathFinder NXT® 3558-2ORTHOSIS, SPINAL PEDICLE FIXATION2 reports
- PathFinder NXT® 3558-50ORTHOSIS, SPINAL PEDICLE FIXATION2 reports
- PathFinder NXT® 3505-4545Orthosis, spinal pedicle fixation, for degenerative disc disease1 report
- PathFinder NXT® 3505-6530Orthosis, spinal pedicle fixation, for degenerative disc disease1 report
- PathFinder NXT® 3510-040Orthosis, spinal pedicle fixation, for degenerative disc disease1 report
- PathFinder NXT® 3512-120Orthosis, spondylolisthesis spinal fixation1 report
- PathFinder NXT® 3570-1ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- PathFinder NXT® 3570-2ORTHOSIS, SPINAL PEDICLE FIXATION1 report
Recent PathFinder NXT adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 10, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25785390 ↗InjuryMay 21, 2025Fracture; Fracture
IT WAS REPORTED THAT THE HEAD OF A PATHFINDER NXT CANNULATED POLY SCREW BROKE OFF DURING EXTRACTION AND SHAFT WAS NOT RECOVERED. THE EXTRACTION WAS BEING PERFORMED BECAUSE THE DOCTOR JUDGED BONE FUSION TO BE COMPLETE.
Patient problems: Foreign Body In Patient
MAUDE report 22059537 ↗MalfunctionJan 15, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING THE FINAL TIGHTENING OF A SET SCREW, THE TORQUE WRENCH CLICKING SOUND WAS SLUGGISH AND THE SET SCREW WAS DAMAGED. THE SET SCREW WAS REPLACED, HOWEVER THE SECOND AND THIRD SET SCREWS WERE DAMAGED IN THE SAME WAY. THE BONE SCREW WAS ALSO DAMAGED, AND REMOVED AND REPLACED WITH A NEW SCREW, AND THE FINAL TIGHTENING OF THE SET SCREW WAS SUCCESSFUL. THIS CAUSED A 15 MINUTE DELAY TO THE PROCEDURE, HOWEVER THERE WAS NO PATIENT IMPACT. THIS IS REPORT FOUR OF FIVE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21163594 ↗MalfunctionNov 20, 2024Break; Break
IT WAS REPORTED THAT A DISTRIBUTOR DISCOVERED A VARIETY OF INSTRUMENTS WITH UNSPECIFIED DEFECTS DURING A ROUTINE INSPECTION. THERE WAS NOT A PATIENT PRESENT AT THE TIME OF INSPECTION. THE MANUFACTURER FOUND TWO PATHFINDER CLOSURE TOP DRIVERS WITH DEFORMED TIPS DURING THEIR INVESTIGATION. THIS IS REPORT TWO OF TWO FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20738994 ↗MalfunctionNov 20, 2024Break; Break
IT WAS REPORTED THAT A DISTRIBUTOR DISCOVERED A VARIETY OF INSTRUMENTS WITH UNSPECIFIED DEFECTS DURING A ROUTINE INSPECTION. THERE WAS NOT A PATIENT PRESENT AT THE TIME OF INSPECTION. THE MANUFACTURER FOUND TWO PATHFINDER CLOSURE TOP DRIVERS WITH DEFORMED TIPS DURING THEIR INVESTIGATION. THIS IS REPORT ONE OF TWO FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20738979 ↗MalfunctionNov 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT INTRA-OPERATIVELY, A PATHFINDER TORQUE RATCHET HANDLE WAS NOT ABLE TO TIGHTEN CLOSURE TOPS PROPERLY, STRIPPING THE THREADS ON FIVE CLOSURE TOPS AND STRIPPING THE INNER DRIVE HEXAGON ON THREE MORE. A PEDICLE SCREW WAS ALSO REPORTED TO HAVE DISASSEMBLED DURING THE SURGERY. THERE WAS NO PATIENT HARM, HOWEVER THERE WAS A 30 MINUTE PROCEDURAL DELAY AS A RESULT OF THIS. THIS IS REPORT ONE OF TEN FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20736754 ↗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 ↗MalfunctionJul 26, 2024Wrong Label; Wrong Label
IT WAS REPORTED THAT A PATHFINDER STRAIGHT PERCUTANEOUS ROD WAS FOUND IN PACKAGING LABELLED FOR A CURVED ROD. THIS WAS DISCOVERED AT THE PHARMACY BEFORE BEING SENT AND THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19841215 ↗MalfunctionJun 12, 2024Fracture; Fracture
IT WAS REPORTED THAT FIVE PATHFINDER AND SEQUOIA DRIVERS AND REVISION TOOLS WERE DISCOVERED WITH FRACTURED TIPS AT A DISTRIBUTOR. THERE WAS NO REPORTED PATIENT IMPACT. THIS IS REPORT ONE OF FIVE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19522281 ↗MalfunctionNov 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING SURGERY, FOUR CLOSURE TOPS WERE STRIPPED AND TWO SCREWS WERE DISASSEMBLED. NEW CLOSURE TOPS AND SCREWS WERE USED TO COMPLETE THE CASE. THERE WAS A 30-MINUTE DELAY WITHOUT ANY IMPACT ON THE PATIENT. THIS IS REPORT FIVE OF SIX FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18163574 ↗MalfunctionNov 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING SURGERY, FOUR CLOSURE TOPS WERE STRIPPED AND TWO SCREWS WERE DISASSEMBLED. NEW CLOSURE TOPS AND SCREWS WERE USED TO COMPLETE THE CASE. THERE WAS A 30-MINUTE DELAY WITHOUT ANY IMPACT ON THE PATIENT. THIS IS REPORT SIX OF SIX FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18163553 ↗MalfunctionOct 16, 2023Fracture; Fracture
IT WAS REPORTED THAT A PATHFINDER REDUCTION SCREWDRIVER TIP FRACTURED INTO THREE PIECES DURING SURGERY. THE SURGEON RETRIEVED ALL THREE BROKEN PIECES. INFORMATION REGARDING PATIENT IMPACT IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 17939445 ↗MalfunctionAug 16, 2023Fracture; Device Markings/Labelling Problem; Fracture; Device Markings/Labelling Problem
IT WAS REPORTED THAT A WAREHOUSE DISCOVERED A PATHFINDER REDUCTION SCREWDRIVER WITH A FRACTURED TIP AFTER IT WAS RETURNED FROM A HOSPITAL. THE HOSPITAL DID NOT PROVIDE ANY PATIENT OR SURGICAL INFORMATION WITH THE INSTRUMENT.
Patient problems: Insufficient Information
MAUDE report 17557010 ↗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 ↗MalfunctionJun 7, 2023Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF A SCREWDRIVER BROKE INTRA-OPERATIVELY, PREVENTING FURTHER ENGAGEMENT OF THE SCREW WITH THE SCREWDRIVER. THE FRAGMENT WAS RECOVERED AND ANOTHER SCREWDRIVER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A DELAY OF 40 MINUTES WITHOUT PATIENT IMPACTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17083643 ↗
Other Zimmer Spine, Inc. products
All Zimmer Spine, Inc. 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.
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