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ZEVO™ Anterior Cervical Plate System G7723513Recalls & reported problems

Medtronic Sofamor Danek, Inc. · SCREW G7723513 ZEVO VAR ST 3.5MM X 13MM · Class 2 · Implant

All models of ZEVO Anterior Cervical Plate System (39)

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

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

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20643169328215), received between Jan 2, 2025 and Jan 2, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Migration” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K141632); they may or may not involve this specific model.

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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 3 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Migration3

Patient problems

  • Unspecified Nervous System Problem3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 2, 2025Migration; Migration

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. PRE-OP DIAGNOSIS OF PATIENT WAS DEGENERATIVE DISC DISEASE. IT WAS REPORTED THAT, TWO OF THE SUPERIOR SCREWS AND ONE OF THE INFERIOR SCREWS WERE BACKING OUT. IT WAS NOTED AT 6 WEEK PATIENT POST OP REVIEW. PATIENT DISPLAYED SIGNS OF DYSPRAXIA. NO FURTHER COMPLICATIONS REPORTED AS A RESULT.

    Patient problems: Unspecified Nervous System Problem

    MAUDE report 21052432 ↗
  • MalfunctionJan 2, 2025Migration; Migration

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. PRE-OP DIAGNOSIS OF PATIENT WAS DEGENERATIVE DISC DISEASE. IT WAS REPORTED THAT, TWO OF THE SUPERIOR SCREWS AND ONE OF THE INFERIOR SCREWS WERE BACKING OUT. IT WAS NOTED AT 6 WEEK PATIENT POST OP REVIEW. PATIENT DISPLAYED SIGNS OF DYSPRAXIA. NO FURTHER COMPLICATIONS REPORTED AS A RESULT.

    Patient problems: Unspecified Nervous System Problem

    MAUDE report 21052419 ↗
  • MalfunctionJan 2, 2025Migration; Migration

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. PRE-OP DIAGNOSIS OF PATIENT WAS DEGENERATIVE DISC DISEASE. IT WAS REPORTED THAT, TWO OF THE SUPERIOR SCREWS AND ONE OF THE INFERIOR SCREWS WERE BACKING OUT. IT WAS NOTED AT 6 WEEK PATIENT POST OP REVIEW. PATIENT DISPLAYED SIGNS OF DYSPRAXIA. NO FURTHER COMPLICATIONS REPORTED AS A RESULT.

    Patient problems: Unspecified Nervous System Problem

    MAUDE report 21052357 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K141632. One submission often covers many models, so check the product and lot details in each record.

  • Z-1750-2018 · Mar 23, 2018 · Terminated
    Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Size 4.5mm x 15mm Product Appliance, fixation, spinal intervertebral body

Other APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY devices

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Sources and updates

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