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Trinica® Trinica® 07.00117.002Recalls & reported problems

Zimmer Spine, Inc. · Class 2

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

Adverse event reports
6
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024320925), received between Jul 3, 2020 and Oct 3, 2022 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 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 Deformation3
  • Loosening of Implant Not Related to Bone-Ingrowth2
  • Migration1

Patient problems

  • Fall3
  • No Known Impact Or Consequence To Patient3

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 3, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

    IT WAS REPORTED THAT TWO VIRAGE SCREWS LOOSENED AND ONE DISASSEMBLED POST-OPERATIVELY AFTER THE PATIENT MAY HAVE FALLEN. A REVISION SURGERY WAS PERFORMED WHERE THE THREE SCREWS WERE REMOVED AND REPLACED, AND THE CONSTRUCT WAS EXTENDED FROM LEVELS C4 - T2 TO C3 - T2. THIS IS REPORT TWO OF THREE FOR THIS EVENT.

    Patient problems: Fall

    MAUDE report 15532946 ↗
  • InjuryOct 3, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

    IT WAS REPORTED THAT TWO VIRAGE SCREWS LOOSENED AND ONE DISASSEMBLED POST-OPERATIVELY AFTER THE PATIENT MAY HAVE FALLEN. A REVISION SURGERY WAS PERFORMED WHERE THE THREE SCREWS WERE REMOVED AND REPLACED, AND THE CONSTRUCT WAS EXTENDED FROM LEVELS C4 - T2 TO C3 - T2. THIS IS REPORT ONE OF THREE FOR THIS EVENT.

    Patient problems: Fall

    MAUDE report 15531387 ↗
  • InjuryOct 3, 2022Migration; Migration

    IT WAS REPORTED THAT TWO VIRAGE SCREWS LOOSENED AND ONE DISASSEMBLED POST-OPERATIVELY AFTER THE PATIENT MAY HAVE FALLEN. A REVISION SURGERY WAS PERFORMED WHERE THE THREE SCREWS WERE REMOVED AND REPLACED, AND THE CONSTRUCT WAS EXTENDED FROM LEVELS C4 - T2 TO C3 - T2. THIS IS REPORT THREE OF THREE FOR THIS EVENT.

    Patient problems: Fall

    MAUDE report 15530758 ↗
  • MalfunctionJul 3, 2020Material Deformation; Material Deformation

    IT WAS REPORTED THAT DURING THE PROCEDURE THE DRIVE MECHANISM OF THREE SCREWS WAS DAMAGED. THEY WERE REMOVED AND REPLACED WITH ALTERNATES TO COMPLETE THE CASE. THERE WERE NO REPORTED PATIENT IMPACTS. THIS IS REPORT TWO OF THREE FOR THIS EVENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10229681 ↗
  • MalfunctionJul 3, 2020Material Deformation; Material Deformation

    IT WAS REPORTED THAT DURING THE PROCEDURE THE DRIVE MECHANISM OF THREE SCREWS WAS DAMAGED. THEY WERE REMOVED AND REPLACED WITH ALTERNATES TO COMPLETE THE CASE. THERE WERE NO REPORTED PATIENT IMPACTS. THIS IS REPORT THREE OF THREE FOR THIS EVENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10229660 ↗
  • MalfunctionJul 3, 2020Material Deformation; Material Deformation

    IT WAS REPORTED THAT DURING THE PROCEDURE THE DRIVE MECHANISM OF THREE SCREWS WAS DAMAGED. THEY WERE REMOVED AND REPLACED WITH ALTERNATES TO COMPLETE THE CASE. THERE WERE NO REPORTED PATIENT IMPACTS. THIS IS REPORT ONE OF THREE FOR THIS EVENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10229655 ↗

Other APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY devices

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Sources and updates

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