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Instinct™ 046W0AN00002Recalls & reported problems

Zimmer Spine · Class 2

All models of Instinct (2)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Zimmer Spine Instinct spinal fixation system is used to hold the spine steady during surgery for degenerative disc disease. Most of the 51 reports describe hardware that deformed or bent during implantation, with some parts stripping or fracturing when the surgeon tightened them, and no reports mention deaths or injuries. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
51
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 00889024339910), received between Jul 7, 2020 and Nov 17, 2021 — classified as 51 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (49 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.

Most reported problems

Device problems

  • Material Deformation49
  • Fracture2
  • Naturally Worn2

Patient problems

  • No Clinical Signs, Symptoms or Conditions25
  • No Consequences Or Impact To Patient18
  • No Known Impact Or Consequence To Patient8

Recent adverse event reports

The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 17, 2021Material Deformation; Material Deformation

    IT WAS REPORTED THAT SIX BLOCKERS STRIPPED DURING FINAL TIGHTENING INTRA-OPERATIVELY. THEY WERE REMOVED AND REPLACED TO COMPLETE THE PROCEDURE WITHOUT PATIENT IMPACTS. THIS IS REPORT SIX OF SIX FOR THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12831821 ↗
  • MalfunctionNov 17, 2021Material Deformation; Material Deformation

    IT WAS REPORTED THAT SIX BLOCKERS STRIPPED DURING FINAL TIGHTENING INTRA-OPERATIVELY. THEY WERE REMOVED AND REPLACED TO COMPLETE THE PROCEDURE WITHOUT PATIENT IMPACTS. THIS IS REPORT FIVE OF SIX FOR THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12831808 ↗
  • MalfunctionNov 17, 2021Material Deformation; Material Deformation

    IT WAS REPORTED THAT SIX BLOCKERS STRIPPED DURING FINAL TIGHTENING INTRA-OPERATIVELY. THEY WERE REMOVED AND REPLACED TO COMPLETE THE PROCEDURE WITHOUT PATIENT IMPACTS.THIS IS REPORT TWO OF SIX FOR THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12831721 ↗
  • MalfunctionNov 17, 2021Material Deformation; Material Deformation

    IT WAS REPORTED THAT SIX BLOCKERS STRIPPED DURING FINAL TIGHTENING INTRA-OPERATIVELY. THEY WERE REMOVED AND REPLACED TO COMPLETE THE PROCEDURE WITHOUT PATIENT IMPACTS. THIS IS REPORT THREE OF SIX FOR THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12831720 ↗
  • MalfunctionNov 17, 2021Material Deformation; Material Deformation

    IT WAS REPORTED THAT SIX BLOCKERS STRIPPED DURING FINAL TIGHTENING INTRA-OPERATIVELY. THEY WERE REMOVED AND REPLACED TO COMPLETE THE PROCEDURE WITHOUT PATIENT IMPACTS. THIS IS REPORT ONE OF SIX FOR THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12831708 ↗
  • MalfunctionNov 17, 2021Material Deformation; Material Deformation

    IT WAS REPORTED THAT SIX BLOCKERS STRIPPED DURING FINAL TIGHTENING INTRA-OPERATIVELY. THEY WERE REMOVED AND REPLACED TO COMPLETE THE PROCEDURE WITHOUT PATIENT IMPACTS. THIS IS REPORT FOUR OF SIX FOR THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12831701 ↗
  • MalfunctionNov 17, 2021Material Deformation; Material Deformation

    IT WAS REPORTED THAT FIVE BLOCKERS WERE STRIPPED DURING SURGERY DURING FINAL TIGHTENING. THE SURGEON HAD TROUBLE LOCKING THEM, SO REMOVED THEM AN FOUND THE DAMAGE. THIS IS REPORT FIVE OF FIVE FOR THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12830895 ↗
  • MalfunctionNov 17, 2021Material Deformation; Material Deformation

    IT WAS REPORTED THAT FIVE BLOCKERS WERE STRIPPED DURING SURGERY DURING FINAL TIGHTENING. THE SURGEON HAD TROUBLE LOCKING THEM, SO REMOVED THEM AN FOUND THE DAMAGE. THIS IS REPORT FOUR OF FIVE FOR THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12830878 ↗
  • MalfunctionNov 17, 2021Material Deformation; Material Deformation

    IT WAS REPORTED THAT FIVE BLOCKERS WERE STRIPPED DURING SURGERY DURING FINAL TIGHTENING. THE SURGEON HAD TROUBLE LOCKING THEM, SO REMOVED THEM AN FOUND THE DAMAGE. THIS IS REPORT THREE OF FIVE FOR THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12830858 ↗
  • MalfunctionNov 17, 2021Material Deformation; Material Deformation

    IT WAS REPORTED THAT FIVE BLOCKERS WERE STRIPPED DURING SURGERY DURING FINAL TIGHTENING. THE SURGEON HAD TROUBLE LOCKING THEM, SO REMOVED THEM AN FOUND THE DAMAGE. THIS IS REPORT TWO OF FIVE FOR THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12830857 ↗
  • MalfunctionNov 17, 2021Material Deformation; Material Deformation

    IT WAS REPORTED THAT FIVE BLOCKERS WERE STRIPPED DURING SURGERY DURING FINAL TIGHTENING. THE SURGEON HAD TROUBLE LOCKING THEM, SO REMOVED THEM AN FOUND THE DAMAGE. THIS IS REPORT ONE OF FIVE FOR THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12830843 ↗
  • MalfunctionMay 18, 2021Material Deformation; Material Deformation

    IT WAS REPORTED THAT TWO BLOCKERS AND ONE SCREW BROKE WHILE FINAL TIGHTENING. WHEN THE FIRST BLOCKER BROKE A SECOND BLOCKER WAS USED. THIS TIME BOTH THE BLOCKER AND THE SCREW BROKE. BOTH THE BLOCKER AND THE SCREW WERE REMOVED AND NEW DEVICES WERE INSERTED. THERE WAS NO REPORTED DELAY OF SURGERY OR IMPACT ON THE PATIENT. THIS IS REPORT TWO OF THREE FOR THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11841697 ↗
  • MalfunctionMay 18, 2021Material Deformation; Material Deformation

    IT WAS REPORTED THAT TWO BLOCKERS AND ONE SCREW BROKE WHILE FINAL TIGHTENING. WHEN THE FIRST BLOCKER BROKE A SECOND BLOCKER WAS USED. THIS TIME BOTH THE BLOCKER AND THE SCREW BROKE. BOTH THE BLOCKER AND THE SCREW WERE REMOVED AND NEW DEVICES WERE INSERTED. THERE WAS NO REPORTED DELAY OF SURGERY OR IMPACT ON THE PATIENT.THIS IS REPORT ONE OF THREE FOR THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11841579 ↗
  • MalfunctionApr 5, 2021Material Deformation; Material Deformation

    IT WAS REPORTED THAT THE THREADS OF 12 PLUGS STRIPPED DURING AN OPERATION. THE PLUGS WERE REPLACED WITH NEW PLUGS. THERE WAS NO REPORTED IMPACT TO THE PATIENT. THIS IS REPORT TWELVE OF TWELVE FOR THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11616473 ↗
  • MalfunctionApr 5, 2021Material Deformation; Material Deformation

    IT WAS REPORTED THAT THE THREADS OF 12 PLUGS STRIPPED DURING AN OPERATION. THE PLUGS WERE REPLACED WITH NEW PLUGS. THERE WAS NO REPORTED IMPACT TO THE PATIENT. THIS IS REPORT TEN OF TWELVE FOR THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11616449 ↗
  • MalfunctionApr 5, 2021Material Deformation; Material Deformation

    IT WAS REPORTED THAT THE THREADS OF 12 PLUGS STRIPPED DURING AN OPERATION. THE PLUGS WERE REPLACED WITH NEW PLUGS. THERE WAS NO REPORTED IMPACT TO THE PATIENT. THIS IS REPORT NINE OF TWELVE FOR THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11616439 ↗
  • MalfunctionApr 5, 2021Material Deformation; Material Deformation

    IT WAS REPORTED THAT THE THREADS OF 12 PLUGS STRIPPED DURING AN OPERATION. THE PLUGS WERE REPLACED WITH NEW PLUGS. THERE WAS NO REPORTED IMPACT TO THE PATIENT. THIS IS REPORT EIGHT OF TWELVE FOR THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11616429 ↗
  • MalfunctionApr 5, 2021Material Deformation; Material Deformation

    IT WAS REPORTED THAT THE THREADS OF 12 PLUGS STRIPPED DURING AN OPERATION. THE PLUGS WERE REPLACED WITH NEW PLUGS. THERE WAS NO REPORTED IMPACT TO THE PATIENT. THIS IS REPORT SEVEN OF TWELVE FOR THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11616380 ↗
  • MalfunctionApr 5, 2021Material Deformation; Material Deformation

    IT WAS REPORTED THAT THE THREADS OF 12 PLUGS STRIPPED DURING AN OPERATION. THE PLUGS WERE REPLACED WITH NEW PLUGS. THERE WAS NO REPORTED IMPACT TO THE PATIENT. THIS IS REPORT SIX OF TWELVE FOR THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11616356 ↗
  • MalfunctionApr 5, 2021Material Deformation; Material Deformation

    IT WAS REPORTED THAT THE THREADS OF 12 PLUGS STRIPPED DURING AN OPERATION. THE PLUGS WERE REPLACED WITH NEW PLUGS. THERE WAS NO REPORTED IMPACT TO THE PATIENT. THIS IS REPORT FIVE OF TWELVE FOR THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11616349 ↗
  • MalfunctionApr 5, 2021Material Deformation; Material Deformation

    IT WAS REPORTED THAT THE THREADS OF 12 PLUGS STRIPPED DURING AN OPERATION. THE PLUGS WERE REPLACED WITH NEW PLUGS. THERE WAS NO REPORTED IMPACT TO THE PATIENT. THIS IS REPORT FOUR OF TWELVE FOR THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11616329 ↗
  • MalfunctionApr 5, 2021Material Deformation; Material Deformation

    IT WAS REPORTED THAT THE THREADS OF 12 PLUGS STRIPPED DURING AN OPERATION. THE PLUGS WERE REPLACED WITH NEW PLUGS. THERE WAS NO REPORTED IMPACT TO THE PATIENT. THIS IS REPORT ELEVEN OF TWELVE FOR THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11616301 ↗
  • MalfunctionApr 5, 2021Material Deformation; Material Deformation

    IT WAS REPORTED THAT THE THREADS OF 12 PLUGS STRIPPED DURING AN OPERATION. THE PLUGS WERE REPLACED WITH NEW PLUGS. THERE WAS NO REPORTED IMPACT TO THE PATIENT. THIS IS REPORT THREE OF TWELVE FOR THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11616280 ↗
  • MalfunctionApr 5, 2021Material Deformation; Material Deformation

    IT WAS REPORTED THAT THE THREADS OF 12 PLUGS STRIPPED DURING AN OPERATION. THE PLUGS WERE REPLACED WITH NEW PLUGS. THERE WAS NO REPORTED IMPACT TO THE PATIENT. THIS IS REPORT TWO OF TWELVE FOR THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11616271 ↗
  • MalfunctionApr 5, 2021Material Deformation; Material Deformation

    IT WAS REPORTED THAT THE THREADS OF 12 PLUGS STRIPPED DURING AN OPERATION. THE PLUGS WERE REPLACED WITH NEW PLUGS. THERE WAS NO REPORTED IMPACT TO THE PATIENT. THIS IS REPORT ONE OF TWELVE FOR THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11616259 ↗

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Sources and updates

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