PYRAMESH® C Titanium Mesh 905-800Recalls & reported problems
Medtronic Sofamor Danek, Inc. · MESH 905-800 PYRM END RING SET SCRW · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 20673978081148), received between Jan 16, 2020 and Jan 16, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
Patient problems
- 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.
MalfunctionJan 16, 2020Break; Break
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH L3 TUMOR; AND UNDERWENT L3 CORPECTOMY AND INSERTION OF CAGE. INTRA-OP, WHEN INSERTING THE SCREW INTO THE END PLATE IN THE CAGE, THE SCREW HEAD BROKE OFF THE SHAFT. THE SHAFT REMAINS IN THE ENDPLATE, WHICH IS IMPLANTED IN THE PATIENT. THE SCREW HEAD WAS EXPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9597293 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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