X-MESH 188901028Recalls & reported problems
Medos International Sàrl · X-MESH EXPANDABLE CAGE SYSTEM EXPANDABLE VERTEBRAL BODY REPLACEMENT, LATERAL, MEDIUM 28 - 38mm, 0/0 DEGREES · Class 2 · Implant
Data updated Oct 13, 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 10705034159690), received between Aug 29, 2018 and Aug 29, 2018 — 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 29, 2018Break; Break
IT WAS REPORTED THAT A SPINAL SURGERY(NOT A REVISION) TOOK PLACE ON (B)(6) 2018 WHERE THE FOLLOWING EVENTS HAPPENED WITH SET # XMPC-40: PART # 2889-00-000 LOT BR607613 CAGE COULD NOT BE IMPLANTED AS THE INSERTER BROKE, PART #1889-01-233 LOT BDC13SG FAILED TO LOCK, PART #1889-01-028 LOT BDCG3TK BROKE, PART # 1889-21-028 LOT BDJF3SC WOULD NOT RELEASE FROM DRIVER. THERE WERE ALTERNATE PARTS AVAILABLE TO COMPLETE THE SURGERY. AS A RESULT OF THE REPORTED ISSUES, THE PATIENT CONSEQUENCES WERE AS FOLLOWS: A PROLONGED SURGERY OF 90 MINUTES , THE VENA CAVA WAS TORN AND HAD TO BE REPAIRED, LOSS OF BLOOD DUE TO MULTIPLE ATTEMPTS TO COMPLETE THE SURGERY. SURGEON REPORT MAY BE AVAILABLE IN THE NEAR FUTURE
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7826088 ↗
Other SPINAL VERTEBRAL BODY REPLACEMENT DEVICE devices
- X-CORE 7160014Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7220016Nuvasive, 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 7180018Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 33-54 mm, 7-10 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 18-22 mm, 5-8 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- X-CORE 7220018Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7180016Nuvasive, 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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