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Pyramesh® Implant System 905-407Recalls & reported problems

Medtronic Sofamor Danek, Inc. · MESH 905-407 PYRM 10X14X70 OVOID · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00673978080901), received between Nov 2, 2020 and Nov 2, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Fracture1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 2, 2020Fracture; Fracture

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN INDICATION OF LUMBAR VERTEBRAL TUMOR IN NEED OF OSTEOTOMY SURGERY USED IN SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE HAS FRACTURED DURING THE SURGERY. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. THERE WERE NO FRAGMENTS IN THE PATIENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

    MAUDE report 10768697 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.