SequoiaRecalls & reported problems across all models

We found 3 models of Sequoia by Zimmer Spine, Inc. in the FDA's device registry (GUDID). Together they are named in 187 adverse event reports in the FDA's MAUDE database, received between Sep 4, 2019 and May 8, 2026 — classified as 4 injuries, 183 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (184 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 Sequoia problems

Sequoia models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Sequoia® 3301-1

  Orthosis, spinal pedicle fixation, for degenerative disc disease
  184 reports
• Sequoia® 3363-1

  ORTHOSIS, SPINAL PEDICLE FIXATION
  2 reports
• Sequoia® 3367-2

  Orthosis, spinal pedicle fixation, for degenerative disc disease
  1 report

Recent Sequoia adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Material Deformation

  A CLOSURE TOP WAS RETURNED TO THE MANUFACTURER WITH FRACTURED/STRIPPED THREADS. THIS DAMAGE IS BELIEVED TO HAVE OCCURRED INTRA-OPERATIVELY, HOWEVER THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25125350 ↗
• MalfunctionJan 28, 2026Material Deformation

  IT WAS REPORTED THAT BOTH THE INNER HEXAGON AND OUTER THREADS OF THREE SEQUOIA CLOSURE TOPS WERE STRIPPED DURING FINAL TIGHTENING INTRA-OPERATIVELY. NEW CLOSURE TOPS WERE USED TO COMPLETE THE SURGERY AND THERE WAS NO PATIENT IMPACT; HOWEVER, THERE WAS A 10 MINUTE DELAY TO EXCHANGE THE CLOSURE TOPS. THIS IS REPORT TWO OF THREE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24203508 ↗
• MalfunctionJan 28, 2026Material Deformation

  IT WAS REPORTED THAT BOTH THE INNER HEXAGON AND OUTER THREADS OF THREE SEQUOIA CLOSURE TOPS WERE STRIPPED DURING FINAL TIGHTENING INTRA-OPERATIVELY. NEW CLOSURE TOPS WERE USED TO COMPLETE THE SURGERY AND THERE WAS NO PATIENT IMPACT; HOWEVER, THERE WAS A 10 MINUTE DELAY TO EXCHANGE THE CLOSURE TOPS. THIS IS REPORT ONE OF THREE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24203441 ↗
• MalfunctionDec 22, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT A PATHFINDER CLOSURE TOP INNER HEXAGON STRIPPED INTRA-OP DURING FINAL TIGHTENING BUT DID NOT RESULT IN ANY PATIENT HARM AND ONLY CAUSED A 10 MINUTE PROCEDURAL DELAY. ANOTHER CLOSURE TOP WAS USED TO FINISH THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23869385 ↗
• MalfunctionDec 18, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING INSPECTION OF A FIELD RETURN FROM A HOSPITAL, A WAREHOUSE DISCOVERED A SEQUOIA SCREWDRIVER WITH A DAMAGED TIP. THERE WAS NO REPORTED PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23841822 ↗
• MalfunctionDec 18, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THREE PATHFINDER CLOSURE TOPS WERE DAMAGED WHEN SURGEON FINAL TORQUED THEM: TWO SCREW¿S THREADS WERE BROKEN, AND ONE'S INNER HEXAGON STRIPPED OFF. THERE WAS NO PATIENT IMPACT; HOWEVER, THERE WAS A 30 MINUTE DELAY TO PREPARE OTHER CLOSURE TOPS. THIS IS REPORT THREE OF THREE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23841439 ↗
• MalfunctionDec 18, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THREE PATHFINDER CLOSURE TOPS WERE DAMAGED WHEN SURGEON FINAL TORQUED THEM: TWO SCREW¿S THREADS WERE BROKEN, AND ONE'S INNER HEXAGON STRIPPED OFF. THERE WAS NO PATIENT IMPACT; HOWEVER, THERE WAS A 30 MINUTE DELAY TO PREPARE OTHER CLOSURE TOPS. THIS IS REPORT TWO OF THREE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23840504 ↗
• MalfunctionDec 18, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THREE PATHFINDER CLOSURE TOPS WERE DAMAGED WHEN SURGEON FINAL TORQUED THEM: TWO SCREW¿S THREADS WERE BROKEN, AND ONE'S INNER HEXAGON STRIPPED OFF. THERE WAS NO PATIENT IMPACT; HOWEVER, THERE WAS A 30 MINUTE DELAY TO PREPARE OTHER CLOSURE TOPS. THIS IS REPORT ONE OF THREE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23840470 ↗
• MalfunctionSep 11, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A SURGERY, THE INNER HEXAGON OF A CLOSURE TOP WAS STRIPPED DURING FINAL TIGHTENING. THERE WAS NO PATIENT HARM AND THE SURGERY WAS COMPLETED WITH ANOTHER CLOSURE TOP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23032849 ↗
• MalfunctionMay 14, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THREE SEQUOIA CLOSURE TOPS WERE STRIPPED DURING SURGERY. A FOURTH CLOSURE TOP WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT IMPACT; HOWEVER, THERE WAS A 30 MINUTE DELAY. THIS IS REPORT THREE OF THREE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22020401 ↗
• MalfunctionMay 14, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THREE SEQUOIA CLOSURE TOPS WERE STRIPPED DURING SURGERY. A FOURTH CLOSURE TOP WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT IMPACT; HOWEVER, THERE WAS A 30 MINUTE DELAY. THIS IS REPORT TWO OF THREE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22020370 ↗
• MalfunctionMay 14, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THREE SEQUOIA CLOSURE TOPS WERE STRIPPED DURING SURGERY. A FOURTH CLOSURE TOP WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT IMPACT; HOWEVER, THERE WAS A 30 MINUTE DELAY. THIS IS REPORT ONE OF THREE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22020346 ↗
• MalfunctionJan 29, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING TIGHTENING INTRA-OPERATIVELY, THE OUTER THREADS AND THE DRIVE FEATURE OF A CLOSURE TOP STRIPPED. THERE WAS A TEN MINUTE DELAY TO THE PROCEDURE WHILE THE CLOSURE TOP WAS REMOVED AND REPLACED, BUT NO FURTHER PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21266007 ↗
• MalfunctionJan 22, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT FOUR PATHFINDER CLOSURE TOPS WERE STRIPPED DURING TORQUE INTRA-OPERATIVELY. THIS RESULTED IN A 30 MINUTE PROCEDURAL DELAY BUT NO PATIENT IMPACT. THIS IS REPORT FOUR OF FOUR FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21210038 ↗
• MalfunctionJan 22, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT FOUR PATHFINDER CLOSURE TOPS WERE STRIPPED DURING TORQUE INTRA-OPERATIVELY. THIS RESULTED IN A 30 MINUTE PROCEDURAL DELAY BUT NO PATIENT IMPACT.THIS IS REPORT THREE OF FOUR FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21210033 ↗

Other Zimmer Spine, Inc. products

• Vitality11 models · 97 reports
• PathFinder NXT13 models · 35 reports