TiMesh® 015-042Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00673978002668), received between Jul 28, 2023 and Oct 9, 2024 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 9, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A PLATE FOR CRANIAL REPAIR. IT WAS REPORTED THAT THE SURGEON USED THE CRANIOMAXILLOFACIAL FIXATION SYSTEM TO INSTALL A 2-HOLE 8MM STANDARD STRAIGHT PLATE. THE FIRST SCREW WAS SCREWED IN NORMALLY. AFTER THE SECOND SCREW WAS SCREWED IN, IT WAS FOUND THAT THE CONNECTION PLATE WAS BROKEN. THE BROKEN PART WAS IMMEDIATELY REMOVED, AND THE CIRCULATING NURSE REPLACED THE CRANIOMAXILLOFACIAL FIXATION SYSTEM, WHICH THE SURGEON USED NORMALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20407483 ↗
• MalfunctionJan 4, 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 18446863 ↗
• MalfunctionJan 4, 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 18446804 ↗
• MalfunctionJan 4, 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 18446763 ↗
• 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 18439020 ↗
• 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 18438921 ↗
• InjuryJul 28, 2023Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A DURAREPAIR. IT WAS REPORTED ON (B)(6) 2023, 17:45 ACCORDING TO THE NEEDS OF THE SURGERY, THE SURGEON USED MEDTRONIC CONNECTING PLATES AND NAILS. AT 17:50, WHEN THE SURGEON INSTALLED THE NAIL, THE CONNECTING PLATE BROKE. AT 18:00, A NEW MEDTRONIC CONNECTING PLATE WAS REPLACED, AND THE SURGERY PROCEEDED NORMALLY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17413273 ↗