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ANATOMIC PEEK PTC Cervical Fusion System 5030541Recalls & reported problems

Medtronic Sofamor Danek, Inc. · CAGE 5030541 ANATOMIC PTC 14X11X5MM · Class 2 · Implant

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

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169357587), received between Nov 21, 2018 and Jun 13, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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

  • Device Dislodged or Dislocated1
  • Migration or Expulsion of Device1

Patient problems

  • Neurological Deficit/Dysfunction1
  • No Clinical Signs, Symptoms or Conditions1
  • Stenosis1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING REVISION SURGERY FOR CAGE DISLODGEMENT. IT WAS REPORTED THAT AFTER INSTALLING THE CAGE, A FEW DAYS LATER THE CAGE WAS DISLODGED. REVISION WAS PERFORMED TO EXPLANT THE CAGE. PROCEDURE OR TECHNIQUE PERFORMED WAS STAND ALONE C5/6 ANTERIOR CERVICAL DISCECTOMY AND FUSION. HOSPITALIZATION WAS EXTENDED DUE TO CAGE DISLODGEMENT. THE CAGE WAS DISCARDED BY FACILITY AFTER EXPLANT. NO INFORMATION WAS PROVIDED ON PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17117333 ↗
  • InjuryNov 21, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

    IT WAS REPORTED THAT ON PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH CERVICAL SPONDYLOTIC MYELOPATHY AND UNDERWENT ANTERIOR CERVICAL DECOMPRESSION AND FUSION. POST-OP, THE CAGE MOVED FORWARD AFTER THE OPERATION. THE INTERVERTEBRAL DISC HEIGHT MAINTAINED IN THE OPERATION DECREASED, THE FORAMINAL STENOSIS, INTERVERTEBRAL FORAMEN JOINT WORKED AND NEUROLOGICAL SYMPTOM WERE REPORTED AS THE RESULT OF THE EVENT.

    Patient problems: Neurological Deficit/Dysfunction; Stenosis

    MAUDE report 8097248 ↗

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Sources and updates

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