PathFinder NXT® 3505-6550Recalls & reported problems
Zimmer Spine, Inc. · Class 2
All models of PathFinder NXT (13)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024335714), received between Jul 19, 2021 and Nov 20, 2024 — classified as 2 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 ↗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 FOUR OF FOUR FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12188478 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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