SynMesh 495.379Recalls & reported problems
Synthes GmbH · SYNMESH® 22MM X 28MM 88MM HEIGHT (TI) · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034785424), received between Sep 12, 2018 and Sep 12, 2018 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH 4.0MM TITANIUM VECTRA CERVICAL SCREWS (X 4), ONE TITANIUM VECTRA PLATE (1 LEVEL 16MM), AND ONE SYNTHES SYNMESH CAGE ON (B)(6) 2017. ONE MONTH POSTOPERATIVELY, THERE WAS A FIXATION FAILURE NOTED IN A POSTOPERATIVE FLUOROSCOPY IMAGE. THE PATIENT WAS ALSO REPORTED TO HAVE MILD DYSPHONIA. DUE TO THE PATIENT EXHIBITING FEW SYMPTOMS AND CERVICAL STABILITY (CLOTTING WAS PARTIAL) THE PATIENT HAS BEEN UNDER OBSERVATION AND THE DEVICE CONTINUES TO BE IMPLANTED. THERE HAS BEEN AN IMPROVEMENT OF THE DYSPHAGIA BUT IT (THE CONDUCT) STILL REMAINS TO THIS DAY. THIS REPORT IS FOR ONE (1) SYNMESH® 22MM X 28MM 88MM HEIGHT (TI). THIS IS REPORT 1 OF 6 FOR COMPLAINT (B)(4).
Patient problems: No Code Available
MAUDE report 7869479 ↗
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- X-CORE 7180016Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 18-22 mm, 2-5 DegEden Spine Europe SA · 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
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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