X-MESH 288900000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034222592), received between Aug 29, 2018 and Oct 2, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 2, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, BROKEN INSTRUMENT WAS FOUND BEFORE SETTING UP FOR SURGERY. THERE IS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9147057 ↗
• InjuryAug 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: 1. PART # 2889-00-000 LOT BR607613 CAGE COULD NOT BE IMPLANTED AS THE INSERTER BROKE. 2. PART #1889-01-233 LOT BDC13SG FAILED TO LOCK 3. PART #1889-01-028 LOT BDCG3TK BROKE. 4. 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: 1. A PROLONGED SURGERY OF 90 MINUTES. 2. THE VENA CAVA WAS TORN AND HAD TO BE REPAIRED. 3. LOSS OF BLOOD DUE TO MULTIPLE ATTEMPTS TO COMPLETE THE SURGERY. SURGEON REPORT MAY BE AVAILABLE IN THE NEAR FUTURE.

  Patient problems: Blood Loss; Injury

  MAUDE report 7826070 ↗