TiMesh® 015-044Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00673978002682), received between Nov 18, 2016 and Nov 20, 2019 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2019Break; Break

  IT WAS REPORTED THAT WHEN THE PATIENT FINISHED THE FIXATION OF THE SKULL, IT WAS NECESSARY TO USE THE CRANIO-MAXILLOFACIAL FIXATION SYSTEM. WHEN THE FIXATION SCREW WAS FIXED, THE FIXATION HOLE ON THE PLATE OF THE SYSTEM BROKE. IT WAS NOTED THAT THE BROKEN FRAGMENTS DID NOT FALL INTO THE BRAIN. THE DOCTOR REPLACED THE PLATE WITH A NEW ONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9349435 ↗
• MalfunctionFeb 15, 2019Break; Break

  IT WAS REPORTED THAT DURING THE SKULL REPAIR SURGERY, THE PLATE BROKE, AND THE SCREW BROKE IN THE MIDDLE. THE PRODUCTS WERE REPLACED AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8346250 ↗
• MalfunctionJan 8, 2019Fracture; Fracture

  IT WAS REPORTED THE PLATE FRACTURED AT THE EYELET. THE PLATE WAS NEVER IMPLANTED AND WAS REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8227770 ↗
• MalfunctionJan 8, 2019Fracture; Fracture

  IT WAS REPORTED THE PLATE FRACTURED AT THE EYELET. THE PLATE WAS NEVER IMPLANTED AND WAS REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8227765 ↗
• MalfunctionJul 11, 2017Break; Break

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE SCREW HOLES ON THE RIGHT SIDE WERE BROKEN AND THE PLATES WERE REPLACED. ACCORDING TO THE REPORT, THE SCREWS WERE ALSO REPLACED DUE TO SCREW CARD SLOT DEFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6702758 ↗
• MalfunctionJul 11, 2017Break; Break

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE SCREW HOLES ON THE RIGHT SIDE WERE BROKEN AND THE PLATES WERE REPLACED. ACCORDING TO THE REPORT, THE SCREWS WERE ALSO REPLACED DUE TO SCREW CARD SLOT DEFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6702745 ↗
• MalfunctionJul 11, 2017Break; Break

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE SCREW HOLES ON THE RIGHT SIDE WERE BROKEN AND THE PLATES WERE REPLACED. ACCORDING TO THE REPORT, THE SCREWS WERE ALSO REPLACED DUE TO SCREW CARD SLOT DEFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6702657 ↗
• MalfunctionMay 22, 2017Break; Break

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE CONNECTION HOLE BROKE INTRA-OPERATIVELY. ACCORDING TO THE REPORT, THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6582105 ↗
• MalfunctionMay 22, 2017Break; Break

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE CONNECTION HOLE BROKE INTRA-OPERATIVELY. ACCORDING TO THE REPORT, THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6582103 ↗
• MalfunctionDec 15, 2016Break; Break

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PLATE BROKE PRIOR TO SURGERY. ACCORDING TO THE REPORT, THE PRODUCT WAS REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE AND THE PATIENT WAS WELL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6179626 ↗
• MalfunctionDec 15, 2016Break; Break

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PLATE BROKE PRIOR TO SURGERY. ACCORDING TO THE REPORT, THE PRODUCT WAS REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE AND THE PATIENT WAS WELL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6179624 ↗
• MalfunctionNov 18, 2016Break; Break

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PLATE BROKE DURING SURGERY. ACCORDING TO THE REPORT, THE PHYSICIAN REPLACED THE PLATE TO COMPLETE THE SURGERY. REPORTEDLY, THE PATIENT WAS WELL AND NO FRAGMENT REMAINED IN THEIR BODY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6112903 ↗