Pyramesh® Implant System 905-403Recalls & reported problems
Medtronic Sofamor Danek, Inc. · MESH 905-403 PYRM 10 X 14 X 30 OVOID · Class 2 · Implant
Data updated Oct 16, 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 00673978080895), received between Nov 4, 2020 and Nov 4, 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Fracture1
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.
MalfunctionNov 4, 2020Fracture; Fracture
INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURING REPRESENTATIVE REGARDING PATIENT WITH LUMBAR DEGENERATION SUGGESTED FOR LUMBAR DEGENERATION SURGERY. EVENT OCCURRED INTRA-OP. IT WAS REPORTED THAT ON (B)(6) 2019, HCP FROM THE SECOND AFFILIATED HOSPITAL FOUND THE DEVICE DAMAGED DURING PATIENT'S SURGERY, SO HCP APPLIED FOR REPLACEMENT. BREAK WAS REPORTED. NO FRAGMENTS IN PATIENT. NO FURTHER SYMPTOMS OR COMPLICATIONS REPORTED. DEVICE WAS EXPLANTED. UPDATE 2020-OCT-20; THERE WAS TITANIUM MESH FRACTURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10783419 ↗
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- X-CORE 7160012Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 23-32 mm, 2-5 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- X-CORE 7180016Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7160014Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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