X-MESH 288900100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034223032), received between Oct 18, 2017 and Oct 16, 2019 — classified as 1 injury, 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

Recent adverse event reports

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

• MalfunctionOct 16, 2019Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT ON (B)(6) 2019, PREPARED THE XMESH INSERTER WITH THE POSTERIOR INSERTER FOOT ( LEFT-SIDE STANDARD) AND POSTERIOR INSERTER FOOT (LEFT-SIDE SMALL). THE SMALL XMESH CAGE WAS LOADED ONTO THE INSERTER OUTSIDE THE BODY. BEFORE INSERTING IT INTO THE PATIENT, THEY TRIED TO DISENGAGE THE CAGE FROM THE INSERTER AND STUCK. IT WOULD NOT DISENGAGE, IT WAS THOUGHT THAT IT WAS UNDER SOME TENSION SO THE BIG HANDLE HAD TO BE LOOSENED TO COLLAPSE THE INSERTER A LITTLE, THAT DID NOT WORK. FINALLY, THE INSERTER LEFT AND THE STANDARD FOOT TIPS WERE DISENGAGED AND THE CAGE WAS GOT OFF. SOMETHING BENT BUT WAS NOT SURE, THE INSERTER KNOB WOULD NOT TURN, THE TIPS OF THE FOOTED INSERTERS WHERE THOUGHT TO BE BENT SINCE IT COULD NOT BE REMOVED FROM THE IMPLANT. THE SURGEON HAD TO TAKE EXTRA TIME TO TRY AND DISENGAGE THE CAGE ON THE BACK TABLE. THE BACKUP INSERTER HAD WORKED FINE WHEN THE CAGE WAS INSERTED INTO THE PATIENTS BODY, NOTHING WENT WRONG WITH THAT PART IT WAS ONLY ON THE BACK TABLE. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. CONCOMITANT DEVICE REPORTED: XMESH CAGE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1 ) THIS COMPLAINT INVOLVES THREE (3) DEVICES

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9198895 ↗
• InjuryOct 18, 2017Break; Break

  T8/T9 VCR.T6-T11 FUSION. THE VCR WAS PERFORMED, WE TRAILED FOR ENDCAP DIAMETER AND USED DISTRACTOR TO GAUGE HEIGHT. WE LOADED APPROPRIATE X-MESH CAGE, DETACHED INSERTER ONCE LOCKING SCREW WAS FINAL TIGHTENED. WE TOOK A/P AND LATERAL FLUORO SHOTS, AND DETERMINED THAT THE CAGE WAS TOO POSTERIOR AND NEEDED ADJUSTING. WE RE-ATTACHED INSERTER IN-SITU UNLOCKED, COLLAPSED CAGE AND PULLED IT OUT. REIMPLANTED THE CAGE AND AGAIN DETACHED AND TOOK X-RAYS. WE DID THIS ABOUT 7-8 TIMES BEFORE INSERTER BROKE. WHEN THE EXPANDER BROKE, THE KNOB WOULDN'T MOVE SO WE ASSUMED THAT IT WAS B/C LOCKING SCREW WAS STILL ENGAGED SO THE SURGEON PUT A LOT OF FORCE TO LISTEN SCREW. IT WAS LOOSENED SO MUCH THAT IT WOULD NO LONGER ADVANCE. SO, WE HAD TO GO UP TO THE NEXT SIZE IMPLANT. BECAUSE THE INSERTER HAD BROKEN THE SURGEON USED AN ANGLED SCHNIDT TO DROP THE CAGE INTO THE DEFECT, ROTATED IT UNTIL HE GOT EYES ON THE LOCKING SCREW THEN ENGAGED EACH ENDCAP WITH THE FEET OF THE SYNMESH DISTRACTOR, AND USED THAT TO EXTEND THE CAGE, THEN FREEHANDED THE SCREWDRIVER TO FINAL TIGHTEN THE LOCKING NUT.

  Patient problems: Injury

  MAUDE report 6957491 ↗