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ZEVO™ Anterior Cervical Plate System 7714013Recalls & reported problems

Medtronic Sofamor Danek, Inc. · SCREW 7714013 ZEVO VAR SD 4.0MM 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
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169329409), received between Dec 11, 2018 and Dec 6, 2019 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

Most reported problems

Device problems

  • Break3

Patient problems

  • Pain2
  • Device Embedded In Tissue or Plaque1
  • Failure of Implant1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionDec 6, 2019Break; Break

    IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION AT C5-C7. INTRA-OP, THREAD OF SCREW CAME OFF. HENCE, THE PRODUCT WAS EXPLANTED COMPLETELY. THE DAMAGED PRODUCT WAS REPLACED WITH A NEW ONE. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9423076 ↗
  • InjuryApr 12, 2019Break; Break

    TYPE OF PROCEDURE OR TECHNIQUE USED: ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF), LEVELS IMPLANTED: C4-6. IT WAS REPORTED THAT POST-OP, THE IMPLANTED SCREW BROKE WHICH RESULTED IN NON UNION. FRAGMENTS INCLUDING DISTAL END OF SCREW THAT BROKE OFF REMAINED INSIDE THE PATIENT. PATIENT SUFFERED NECK/ARM PAIN AND THE PATIENT UNDERWENT REVISION SURGERY FOR THE REMOVAL OF IMPLANT.

    Patient problems: Failure of Implant; Pain

    MAUDE report 8509173 ↗
  • InjuryDec 11, 2018Break; Break

    TYPE OF PROCEDURE OR TECHNIQUE USED: ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) LEVELS IMPLANTED: C4-6 IT WAS REPORTED THAT POST-OP, THE IMPLANTED SCREW BROKE WHICH RESULTED IN NON UNION. FRAGMENTS INCLUDING DISTAL END OF SCREW THAT BROKE OFF REMAINED INSIDE THE PATIENT. PATIENT SUFFERED NECK/ARM PAIN AND THE PATIENT UNDERWENT REVISION SURGERY FOR THE REMOVAL OF IMPLANT.

    Patient problems: Device Embedded In Tissue or Plaque; Pain

    MAUDE report 8149713 ↗

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

How reports and recalls are matched · Editorial policy · Report an error on this page