TiMesh 015-044Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00643169620292), received between Jan 31, 2018 and Jan 29, 2024 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Break” (24 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CRANIAL REPAIR DEVICE. IT WAS REPORTED THAT DURING THE OPERATION, THE PATIENT'S SKULL WAS FRACTURED REQUIRING THE USE OF A CRANIOFACIAL OSTEOSYNTHESIS SYSTEM. WHEN CONNECTED AND FIXED, THE REDUCTION WAS MAINTAINED, THE CRANIAL BONE PLATE BROKE DURING THE SCREW INSERTION PROCESS. THE DEVICE WAS REPLACED WITH A NEW CONNECTING PIECE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18595124 ↗
• MalfunctionJan 25, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A PLATE USED FOR CRANIAL REPAIR. IT WAS REPORTED THAT DURING THE OPERATION, THE PATIENT'S SKULL WAS BROKEN, AND A CRANIOFACIAL OSTEOSYNTHESIS SYSTEM WAS REQUIRED. DURING THE USE OF THE SYSTEM, WHEN CONNECTED AND FIXED, AND THE REDUCTION WAS MAINTAINED, THE CRANIAL BONE PLATE BROKE DURING THE SCREW INSERTION PROCESS. THE DEVICE WAS RETURNED TO THE HOSPITAL LOGISTICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18579852 ↗
• MalfunctionDec 18, 2023Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CRANIAL REPAIR PLATE. IT WAS REPORTED THE SURGEON WAS PERFORMING CRANIOFACIAL SURGERY, AND THE DEVICE BROKE. THE DEVICE WAS REPLACED WITH ANOTHER ONE TO COMPLETE THE SURGERY. THERE WAS A PROCEDURE DELAY OF 30 MINUTES. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18344900 ↗
• MalfunctionDec 18, 2023Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CRANIAL REPAIR PLATE. IT WAS REPORTED THE SURGEON WAS PERFORMING CRANIOFACIAL SURGERY, AND THE DEVICE BROKE. THE DEVICE WAS REPLACED WITH ANOTHER ONE TO COMPLETE THE SURGERY. THERE WAS A PROCEDURE DELAY OF 30 MINUTES. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18344459 ↗
• MalfunctionNov 15, 2023Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A PLATE USED FOR CRANIAL REPAIR. IT WAS REPORTED THAT AFTER OPENING THE PACKAGE, THERE WAS A QUALITY PROBLEM OF THE CONNECTING PLATE AS IT WAS DAMAGED. THE EVENT WAS NOT ASSOCIATED WITH A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18139290 ↗
• MalfunctionSep 28, 2023Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING FIXING THE PATIENT'S SKULL. IT WAS REPORTED THAT DURING THE SURGERY, WHEN USING THE SCREW TO FIX THE CONNECTING PLATE, THREE CONSECUTIVE CONNECTING PLATES WERE DEFORMED AND FRACTURED DUE TO STRESS. IT WAS INDICATED THE PRODUCTS WERE DAMAGED; HOWEVER, THE BROKEN PIECES DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED BY REPLACING WITH THE SAME MODEL PRODUCT. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17834893 ↗
• MalfunctionSep 28, 2023Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING FIXING THE PATIENT'S SKULL. IT WAS REPORTED THAT DURING THE SURGERY, WHEN USING THE SCREW TO FIX THE CONNECTING PLATE, THREE CONSECUTIVE CONNECTING PLATES WERE DEFORMED AND FRACTURED DUE TO STRESS. IT WAS INDICATED THE PRODUCTS WERE DAMAGED; HOWEVER, THE BROKEN PIECES DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED BY REPLACING WITH THE SAME MODEL PRODUCT. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17834882 ↗
• MalfunctionSep 28, 2023Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING FIXING THE PATIENT'S SKULL. IT WAS REPORTED THAT DURING THE SURGERY, WHEN USING THE SCREW TO FIX THE CONNECTING PLATE, THREE CONSECUTIVE CONNECTING PLATES WERE DEFORMED AND FRACTURED DUE TO STRESS. IT WAS INDICATED THE PRODUCTS WERE DAMAGED; HOWEVER, THE BROKEN PIECES DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED BY REPLACING WITH THE SAME MODEL PRODUCT. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17834820 ↗
• MalfunctionApr 18, 2023Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A DEVICE BEING USED FOR A CRANIAL CLOSURE SURGERY. THE SURGEON WAS ABOUT TO DISASSEMBLE THE DEVICE THAT HAD BEEN STERILIZED IN THE DISINFECTION SUPPLY ROOM AND FOUND THAT THE POSITION OF THE SCREW ON THE PRODUCT WAS BROKEN. THE DEVICE DID NOT HAVE CONTACT WITH THE PATIENT BUT IT DID HAVE CONTACT WITH THE STERILE FIELD. A NEW CONNECTING PIECE WAS USED FOR THE SURGERY. THERE WAS NO IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16762849 ↗
• MalfunctionMar 28, 2022Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CONNECTION PLATE AND SCREW. IT WAS REPORTED THAT WHEN IMPLANTING THE CONNECTED PLATE AND FIXED SCREW INTO THE PATIENT, THE POSITION OF THE SCREW HOLE WAS DEFORMED WITH NO FORCE, AND THE SITE WAS FORCED TO REPLACE IT WITH A NEW CONNECTED PLATE AND 2 SCREWS. THERE WAS NO REPORTED IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE SCREW HOLES WERE DEFORMED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13933983 ↗
• MalfunctionAug 10, 2021Break; Break

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE WERE NORMAL SURGICAL PROCEDURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12304951 ↗
• MalfunctionAug 10, 2021Break; Break

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE WERE NORMAL SURGICAL PROCEDURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12304849 ↗
• MalfunctionJan 8, 2021Break; Break

  IT WAS REPORTED THAT DURING THE INTRAOPERATIVE IMPLANTATION PROCESS, IT WAS FOUND THAT THE SCREW HOLE ON THE PLATE WAS DEFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11141143 ↗
• MalfunctionJan 8, 2021Break; Break

  IT WAS REPORTED THAT DURING THE INTRAOPERATIVE IMPLANTATION PROCESS, IT WAS FOUND THAT THE SCREW HOLE ON THE PLATE WAS DEFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11141136 ↗
• MalfunctionJan 8, 2021Break; Break

  IT WAS REPORTED THAT DURING THE INTRAOPERATIVE IMPLANTATION PROCESS, IT WAS FOUND THAT THE SCREW HOLE ON THE PLATE WAS DEFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11141131 ↗
• MalfunctionJan 8, 2021Break; Break

  IT WAS REPORTED THAT DURING THE INTRAOPERATIVE IMPLANTATION PROCESS, IT WAS FOUND THAT THE SCREW HOLE ON THE PLATE WAS DEFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11141099 ↗
• MalfunctionJan 8, 2021Break; Break

  IT WAS REPORTED THAT DURING THE INTRAOPERATIVE IMPLANTATION PROCESS, IT WAS FOUND THAT THE SCREW HOLE ON THE PLATE WAS DEFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11141094 ↗
• MalfunctionDec 23, 2019Break; Break

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9510987 ↗
• MalfunctionDec 23, 2019Break; Break

  IT WAS REPORTED THAT DURING THE SURGERY, THE SCREW BROKE INSIDE THE PATIENT'S BODY WHICH CAUSED DEFORMATION WITH THE CONNECTION PLATE; HOWEVER, THE BROKEN PIECES WERE RETRIEVED. THIS RESULTED IN A PROCEDURE DELAY OF 60 MINUTES. THE DEVICES WERE REPLACED WITH A NEW ONE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9510968 ↗
• MalfunctionDec 23, 2019Break; Break

  IT WAS REPORTED THAT DURING THE SURGERY, THE SCREW BROKE INSIDE THE PATIENT'S BODY WHICH CAUSED DEFORMATION WITH THE CONNECTION PLATE; HOWEVER, THE BROKEN PIECES WERE RETRIEVED. THIS RESULTED IN A PROCEDURE DELAY OF 60 MINUTES. THE DEVICES WERE REPLACED WITH A NEW ONE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9510964 ↗
• MalfunctionDec 23, 2019Break; Break

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9510745 ↗
• MalfunctionJun 7, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CRANIOPLASTY ON (B)(6) 2019 DUE TO A TUMOR. DURING THE OPERATION, THE DEVICE'S HOLE FRACTURED. IT WAS STATED THAT IT WAS REPLACED WITH ANOTHER DEVICE ON SITE. IT EXTENDED THE PROCEDURE BY 10 MINUTES. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8680521 ↗
• MalfunctionMar 7, 2019Break; Break

  IT WAS REPORTED THAT WHEN THE DOCTOR USED THE MATCHING SCREW TO THE PLATE BEING USED TO BREAK INTO THE SKULL, THE PLATE'S HOLE WAS BROKEN AND COULD NOT BE USED NORMALLY. THE OPERATION WAS COMPLETED AFTER REPLACING WITH THE SAME TYPE OF PRODUCT. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8400432 ↗
• 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 8227771 ↗
• MalfunctionJan 31, 2018Break; Break

  IT WAS REPORTED THAT WHEN SCREWING IN THE SCREW INTRA-OPERATIVELY, THE CONNECTION HOLE OF THE PLATE BROKE. THE PLATE WAS REPLACED AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7232662 ↗