TiMesh 015-246Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00643169620452), received between Nov 3, 2020 and Jan 3, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING CRANIAL REPAIR PRODUCTS. IT WAS REPORTED THAT WHEN USING THE HAND TOOLS TO TIGHTEN THE SCREW DURING SURGERY, DUE TO THE LACK OF SELF-TAPPING PROPERTIES OF THE SCREW, THE DOCTOR NEEDED TO USE MORE FORCE TO TIGHTEN THE SCREW CAUSING THE SNOWFLAKE PIECE, CONNECTING PIECE, AND SCREW TO DEFORM AND MAKING IT IMPOSSIBLE TO CONTINUE USING IT. IT WAS NOTED THAT THE HOSPITAL SUPPLY ROOM COLLECTED DAMAGED PRODUCTS FROM VARIOUS MANUFACTURERS ON A DAILY BASIS AND PROVIDED THEM TO THE DISTRIBUTOR AT ONE TIME DURING THE INVENTORY PERIOD AT THE END OF THE YEAR. IT WAS ASKED FOR THE DOCTORS TO USE MEDTRONIC PRODUCTS OF THE SAME MODEL INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18438688 ↗
• MalfunctionJan 3, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING CRANIAL REPAIR PRODUCTS. IT WAS REPORTED THAT WHEN USING THE HAND TOOLS TO TIGHTEN THE SCREW DURING SURGERY, DUE TO THE LACK OF SELF-TAPPING PROPERTIES OF THE SCREW, THE DOCTOR NEEDED TO USE MORE FORCE TO TIGHTEN THE SCREW CAUSING THE SNOWFLAKE PIECE, CONNECTING PIECE, AND SCREW TO DEFORM AND MAKING IT IMPOSSIBLE TO CONTINUE USING IT. IT WAS NOTED THAT THE HOSPITAL SUPPLY ROOM COLLECTED DAMAGED PRODUCTS FROM VARIOUS MANUFACTURERS ON A DAILY BASIS AND PROVIDED THEM TO THE DISTRIBUTOR AT ONE TIME DURING THE INVENTORY PERIOD AT THE END OF THE YEAR. IT WAS ASKED FOR THE DOCTORS TO USE MEDTRONIC PRODUCTS OF THE SAME MODEL INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18438646 ↗
• MalfunctionJan 3, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING CRANIAL REPAIR PRODUCTS. IT WAS REPORTED THAT WHEN USING THE HAND TOOLS TO TIGHTEN THE SCREW DURING SURGERY, DUE TO THE LACK OF SELF-TAPPING PROPERTIES OF THE SCREW, THE DOCTOR NEEDED TO USE MORE FORCE TO TIGHTEN THE SCREW CAUSING THE SNOWFLAKE PIECE, CONNECTING PIECE, AND SCREW TO DEFORM AND MAKING IT IMPOSSIBLE TO CONTINUE USING IT. IT WAS NOTED THAT THE HOSPITAL SUPPLY ROOM COLLECTED DAMAGED PRODUCTS FROM VARIOUS MANUFACTURERS ON A DAILY BASIS AND PROVIDED THEM TO THE DISTRIBUTOR AT ONE TIME DURING THE INVENTORY PERIOD AT THE END OF THE YEAR. IT WAS ASKED FOR THE DOCTORS TO USE MEDTRONIC PRODUCTS OF THE SAME MODEL INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18438595 ↗
• MalfunctionJan 3, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING CRANIAL REPAIR PRODUCTS. IT WAS REPORTED THAT WHEN USING THE HAND TOOLS TO TIGHTEN THE SCREW DURING SURGERY, DUE TO THE LACK OF SELF-TAPPING PROPERTIES OF THE SCREW, THE DOCTOR NEEDED TO USE MORE FORCE TO TIGHTEN THE SCREW CAUSING THE SNOWFLAKE PIECE, CONNECTING PIECE, AND SCREW TO DEFORM AND MAKING IT IMPOSSIBLE TO CONTINUE USING IT. IT WAS NOTED THAT THE HOSPITAL SUPPLY ROOM COLLECTED DAMAGED PRODUCTS FROM VARIOUS MANUFACTURERS ON A DAILY BASIS AND PROVIDED THEM TO THE DISTRIBUTOR AT ONE TIME DURING THE INVENTORY PERIOD AT THE END OF THE YEAR. IT WAS ASKED FOR THE DOCTORS TO USE MEDTRONIC PRODUCTS OF THE SAME MODEL INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18438469 ↗
• MalfunctionJan 28, 2022Break; Break

  IT WAS REPORTED THAT DURING THE OPERATION, THE SCREW SLIPPED AND BROKE AS WELL AS THE CONNECTING PIECE AND CAP HOLE BROKE ON THE PLATE. THE PRODUCTS WERE REPLACED WITH THE SAME PRODUCT. THIS EVENT RESULTED IN A PROCEDURE DELAY OF 1 MINUTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13387511 ↗
• MalfunctionJan 28, 2022Break; Break

  IT WAS REPORTED THAT DURING THE OPERATION, THE SCREW SLIPPED AND BROKE AS WELL AS THE CONNECTING PIECE AND CAP HOLE BROKE ON THE PLATE. THE PRODUCTS WERE REPLACED WITH THE SAME PRODUCT. THIS EVENT RESULTED IN A PROCEDURE DELAY OF 1 MINUTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13387394 ↗
• MalfunctionJan 28, 2022Break; Break

  IT WAS REPORTED THAT DURING THE OPERATION, THE SCREW SLIPPED AND BROKE AS WELL AS THE CONNECTING PIECE AND CAP HOLE BROKE ON THE PLATE. THE PRODUCTS WERE REPLACED WITH THE SAME PRODUCT. THIS EVENT RESULTED IN A PROCEDURE DELAY OF 1 MINUTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13386432 ↗
• MalfunctionJan 28, 2022Break; Break

  IT WAS REPORTED THAT DURING THE OPERATION, THE SCREW SLIPPED AND BROKE AS WELL AS THE CONNECTING PIECE AND CAP HOLE BROKE ON THE PLATE. THE PRODUCTS WERE REPLACED WITH THE SAME PRODUCT. THIS EVENT RESULTED IN A PROCEDURE DELAY OF 1 MINUTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13386203 ↗
• MalfunctionNov 3, 2020Break; Break

  IT WAS REPORTED THAT DURING THE SURGERY, THE SCREW SLIPPED, THE SCREW BROKE, AND THE CONNECTING PLATE AND TITANIUM CAP HOLE BROKE. THIS RESULTED IN A PROCEDURE DELAY OF 2 MINUTES. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCTS. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THIS PROBLEM HAD BEEN OCCURRING SINCE (B)(6) 2018; HOWEVER, THIS WAS THE FIRST TIME THE HOSPITAL HAD NOTIFIED THE DISTRIBUTOR OF THE QUALITY PROBLEMS. IT WAS NOTED THAT THE TITANIUM PRODUCTS NEED TO BE DISINFECTED IN THE HOSPITAL SUPPLY ROOM AFTER UNPACKING, AND THEN SENT TO THE OPERATING ROOM. SIMILAR PRODUCTS ON THE MARKET MAY CAUSE THE PRODUCT TO BREAK DUE TO MANUAL OPERATION AND OTHER REASONS DURING THE DISINFECTION PROCESS. THIS COMPENSATION MAINLY BELONGED TO THE OBVIOUS BROKEN PRODUCTS PICKED OUT BY THE STAFF IN THE SUPPLY ROOM DURING THE DISINFECTION OR AFTER THE DOCTOR OPENED THE DISINFECTION PACKAGE IN THE OPERATING ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10780011 ↗