TiMesh 016-152Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169620643), received between Feb 10, 2023 and Apr 28, 2023 — 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 16, 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.

• InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A TIMESH DEVICE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED TITANIUM MESH REJECTION AFTER SURGERY, SKIN LESIONS, AND TITANIUM MESH EXPOSURE. THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO "HEAD TRAUMA AND A SKULL DEFECT FOR MORE THAN 4 MONTHS AFTER CRANIOTOMY." THE PATIENT UNDERWENT RIGHT FRONTOTEMPORAL AND PARIETAL SKULL DEFECT REPAIR ON (B)(6) 2023. AFTER THE OPERATION, THE PATIENT EXPERIENCED TITANIUM MESH REJECTION, AND UNDERWENT RIGHT FRONTOTEMPORAL AND PARIETAL SKULL DEFECT REPAIR. AFTER THE OPERATION, THE PATIENT EXPERIENCED TITANIUM MESH REJECTION. 3-2, SKIN LESIONS WITH A DIAMETER OF ABOUT 1.5 CM WERE SEEN ON THE RIGHT FOREHEAD OF THE PATIENT, AND A LITTLE TITANIUM MESH WAS PARTIALLY EXPOSED. 3-8, THE PATIENT WAS SENT TO THE OPERATING ROOM, AND THE TITANIUM MESH WAS REMOVED UNDER GENERAL ANESTHESIA WITH ENDOTRACHEAL INTUBATION.

  Patient problems: Post Operative Wound Infection; Unspecified Tissue Injury

  MAUDE report 16829574 ↗
• MalfunctionFeb 10, 2023Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CRANIAL MESH DEVICE BEING USED IN A CRANIOPLASTY. IT WAS REPORTED THAT THE TAIL OF THE SCREW WAS PROTRUDING AND UNEVEN, SO THE WEAK SKIN WAS EASY TO BE COMPRESSED AND NECROTIC; THE SCREW WAS NOT STRONG ENOUGH, AND ITS TEXTURE WAS BRITTLE, SO IT WAS EASY TO BREAK AFTER BEING STRESSED, AND THE TITANIUM PLATE WAS NOT FIXED FIRMLY. THE PLATE HOLE AT THE EDGE OF THE TITANIUM PLATE WAS OVAL, AND THE UPPER SCREW WAS UNEVEN; THE SCREW STRENGTH WAS POOR, AND THE CONTACT PART BETWEEN THE SCREW'S TAIL AND THE SCREWDRIVER WAS EASY TO CRACK WHEN THE FORCE WAS APPLIED. THE DOCTOR TRIED TO MAKE IT AS SMOOTH AS POSSIBLE DURING OPERATION, AND OBSERVED AFTER THE SURGERY. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16353572 ↗