PathFinder NXT® 3505-6540Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024335691), received between Nov 4, 2020 and May 21, 2025 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. 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 Component2
- Fracture1
- Material Deformation1
Patient problems
- No Known Impact Or Consequence To Patient2
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionMay 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A PATHFINDER NXT CANNULATED POLYAXIAL SCREW DISASSEMBLED WHILE TRYING TO INSTALL IT IN THE PATIENT INTRAOPERATIVELY. IT WAS REMOVED FROM THE PATIENT WITHOUT PATIENT IMPACTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16974017 ↗MalfunctionNov 6, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A PEDICLE SCREW DISASSEMBLED AFTER BEING INSTALLED INTRA-OPERATIVELY. THE SCREW WAS REMOVED AND REPLACED TO COMPLETED THE PROCEDURE. THERE WERE NO ABNORMALITIES SEEN ON THE SCREW PRIOR TO USAGE. THERE WERE NO REPORTED PATIENT HEALTH IMPACTS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10800577 ↗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 THREE OF FOUR FOR THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10785907 ↗
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.
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