TiMesh® 9001640Recalls & reported problems

Summary

The FDA's MAUDE database contains 132 adverse event reports that list this exact device (DI 20613994106814), received between Jan 4, 2017 and Sep 28, 2023 — classified as 2 injuries, 130 malfunctions.

The most frequently reported specific device problem is “Break” (129 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 132 reports, in the reporter's own words as published by the FDA.

• 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 17834795 ↗
• InjuryJul 6, 2023Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A SCREW. IT WAS REPORTED ON JUNE 1, 2023 DURING FACIAL NERVE MICROVASCULAR DECOMPRESSION, WHEN THE BONE FLAP WAS FIXED WITH SCREW, THE NUT WAS BROKEN AND THE SCREW COULD NOT LOCK THE BONE FLAP. CAUSED THE POSSIBILITY OF BONE FLAP FELL OFF IN THE LATER STAGE. THEREFORE, NEW SCREW WAS REPLACED DURING THE SURGERY, CAUSED SECONDARY INJURY TO THE PATIENT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17268649 ↗
• MalfunctionApr 20, 2023Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A TITANIUM MESH FOR CRANIOPLASTY. DURING THE SURGERY, WHEN THE MESH WAS FIXED WITH A SCREW, THE SCREW NUT SLIPPED AND THE TITANIUM MESH COULD NOT BE FIXED. THE GROOVE ON THE SCREW NUT, THE PART CONTACTING WITH THE SCREWDRIVER, WAS TOO BIG, AND THE SCREWDRIVER COULD NOT CATCH THE SCREW. THERE WAS A DELAY OF 5 MINUTES. THE PRODUCT WAS REPORTED DAMAGED, AND A NEW SCREW WAS USED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16777415 ↗
• MalfunctionApr 20, 2023Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A TITANIUM MESH FOR CRANIOPLASTY. DURING THE SURGERY, WHEN THE MESH WAS FIXED WITH A SCREW, THE SCREW NUT SLIPPED AND THE TITANIUM MESH COULD NOT BE FIXED. THE GROOVE ON THE SCREW NUT, THE PART CONTACTING WITH THE SCREWDRIVER, WAS TOO BIG, AND THE SCREWDRIVER COULD NOT CATCH THE SCREW. THERE WAS A DELAY OF 5 MINUTES. THE PRODUCT WAS REPORTED DAMAGED, AND A NEW SCREW WAS USED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16777378 ↗
• MalfunctionMar 23, 2023Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A SCREW THAT WAS BEING USED DURING A CRANIOPLASTY SURGERY WHERE THEY WERE USING A TITANIUM PLATE FOR THE REPAIR. IT WAS REPORTED THAT THE NUT OF THE SCREW WAS BROKEN AND COULD NOT BE USED. THE DEVICE WAS REPLACED WITH A DIFFERENT BRAND OF SCREW TO COMPLETE THE SURGERY. THERE WAS A REPORTED DELAY IN PROCEDURE OF 10 MINUTES. NO PIECES REMAINED IN THE BODY. THERE WAS NO REPORTED INJURY TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16600785 ↗
• MalfunctionOct 24, 2022Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A SCREWS. IT WAS REPORTED THAT THE FOUR MONTHS AFTER THE OPERATION FOR CEREBRAL HEMORRHAGE, THE PATIENT CAME TO OUR HOSPITAL FOR CRANIOPLASTY. THE SURGERY WAS PERFORMED ON (B)(6) 2022. TEN SCREWS WERE NEEDED TO FIX THE SKULL DURING THE OPERATION, BUT DURING THE OPERATION, IT WAS FOUND THAT THREE SCREWS HAD SOFT HEADS AND COULD NOT BE EMBEDDED IN THE SKILL, WHICH WOULD COULD LEAD TO INSTABILITY OF THE SKULL. THE SCREWS WERE REPLACED AND THE ISSUE WAS RESOLVED. THE INJURY WAS MAINLY CAUSED BY A CEREBRAL HEMORRHAGE PROBLEMS WITH TITANIUM SCREW WAS DISCOVERED DURING IMPLANTATION IN PATIENT'S SKULL. SOFT REFERRED TO THE TIP OF THE TITANIUM SCREW THAT DID NOT DRILL WELL INTO THE SKULL AND WAS EMBEDDED IN THE SKULL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15658871 ↗
• MalfunctionOct 24, 2022Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A SCREWS. IT WAS REPORTED THAT THE FOUR MONTHS AFTER THE OPERATION FOR CEREBRAL HEMORRHAGE, THE PATIENT CAME TO OUR HOSPITAL FOR CRANIOPLASTY. THE SURGERY WAS PERFORMED ON (B)(6) 2022. TEN SCREWS WERE NEEDED TO FIX THE SKULL DURING THE OPERATION, BUT DURING THE OPERATION, IT WAS FOUND THAT THREE SCREWS HAD SOFT HEADS AND COULD NOT BE EMBEDDED IN THE SKILL, WHICH WOULD COULD LEAD TO INSTABILITY OF THE SKULL. THE SCREWS WERE REPLACED AND THE ISSUE WAS RESOLVED. THE INJURY WAS MAINLY CAUSED BY A CEREBRAL HEMORRHAGE PROBLEMS WITH TITANIUM SCREW WAS DISCOVERED DURING IMPLANTATION IN PATIENT'S SKULL. SOFT REFERRED TO THE TIP OF THE TITANIUM SCREW THAT DID NOT DRILL WELL INTO THE SKULL AND WAS EMBEDDED IN THE SKULL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15658844 ↗
• MalfunctionOct 24, 2022Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A SCREWS. IT WAS REPORTED THAT THE FOUR MONTHS AFTER THE OPERATION FOR CEREBRAL HEMORRHAGE, THE PATIENT CAME TO OUR HOSPITAL FOR CRANIOPLASTY. THE SURGERY WAS PERFORMED ON (B)(6) 2022. TEN SCREWS WERE NEEDED TO FIX THE SKULL DURING THE OPERATION, BUT DURING THE OPERATION, IT WAS FOUND THAT THREE SCREWS HAD SOFT HEADS AND COULD NOT BE EMBEDDED IN THE SKILL, WHICH WOULD COULD LEAD TO INSTABILITY OF THE SKULL. THE SCREWS WERE REPLACED AND THE ISSUE WAS RESOLVED. THE INJURY WAS MAINLY CAUSED BY A CEREBRAL HEMORRHAGE PROBLEMS WITH TITANIUM SCREW WAS DISCOVERED DURING IMPLANTATION IN PATIENT'S SKULL. SOFT REFERRED TO THE TIP OF THE TITANIUM SCREW THAT DID NOT DRILL WELL INTO THE SKULL AND WAS EMBEDDED IN THE SKULL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15658783 ↗
• MalfunctionOct 6, 2022Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A SCREW DEVICE. IT WAS REPORTED THAT THE SCREW HEADS WERE BROKEN. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15551313 ↗
• MalfunctionSep 16, 2022Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A SCREW DEVICE. IT WAS REPORTED THAT THE SCREW HEADS WERE BROKEN. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15439669 ↗
• InjuryApr 1, 2022Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A SCREW. THE PATIENT UNDERWENT A SKULL DEFECT REPAIR AND SKULL TITANIUM PLATE PLACEMENT SURGERY IN THE OPERATING ROOM ON (B)(6) 2022. DURING THE PROCEDURE, WHEN THE SURGEON USED A SCREWDRIVER TO INSERT THE SCREW, THE TOP LAYER OF THE SCREW WAS BROKEN. IT WAS REPLACED IMMEDIATELY AND THE PROCEDURE WAS CONTINUED.

  Patient problems: Tissue Breakdown

  MAUDE report 13978522 ↗
• 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 13389273 ↗
• 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 13389271 ↗
• 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 13389258 ↗
• 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 13389255 ↗
• 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 13389245 ↗
• 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 13389233 ↗
• 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 13389227 ↗
• 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 13389219 ↗
• 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 13389211 ↗
• 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 13389210 ↗
• 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 13389202 ↗
• 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 13389191 ↗
• 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 13389186 ↗
• 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 13389183 ↗