TiMesh 015-042Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00643169620278), received between Sep 13, 2018 and Feb 12, 2026 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Break” (26 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2026Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A TITANIUM PLATE FOR CRANIAL REPAIR. IT WAS REPORTED THAT THE CONNECTING PLATE BROKE DURING A CRANIOTOMY. THE PROCEDURE WAS COMPLETED WITH BACK UP PRODUCTS. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24322724 ↗
• MalfunctionSep 16, 2025Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A PLATE USED FOR CRANIAL REPAIR. IT WAS REPORTED THAT THERE WAS BREAKAGE/FRACTURE OF THE PLATE OCCURRED DURING THE DISINFECTION PROCESS. THE PROCEDURE WAS COMPLETED WITH BACK UP PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23063843 ↗
• MalfunctionDec 27, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A PLATE FOR CRANIAL REPAIR. IT WAS REPORTED THAT DURING INSPECTION UPON THE ARRIVAL OF THE PURCHASED GOOD, IT WAS FOUND THAT THE PRODUCT WAS KINKED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21025691 ↗
• MalfunctionSep 3, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A PLATE FOR CRANIAL REPAIR. IT WAS REPORTED THAT DURING THE DISINFECTION PROCESS, THE HOLE EXPANDED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20124948 ↗
• 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 13386396 ↗
• 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 13386302 ↗
• 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 13386260 ↗
• MalfunctionJan 27, 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 13373860 ↗
• 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 10781617 ↗
• 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 10781556 ↗
• MalfunctionNov 3, 2020Break; Break

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT A DISINFECTING AGENT WAS NOT USED AS PART OF THE DISINFECTION PROCESS. THE DISINFECTING PROCESS THAT WAS FOLLOWED WAS CLEAN WATER SHOWER PLUS HIGH TEMPERATURE AND HIGH PRESSURE DISINFECTION. THE PROCESS OF PUTTING LOOSE SCREWS INTO THE BOX WAS OPERATED BY THE WORKERS RESPONSIBLE FOR THE DISINFECTION IN THE HOSPITAL. IT WAS NOTED THAT THE TEMPERATURE WAS 134 DEGREES CELSIUS, AND THE PRESSURE WAS 3BAR.

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

  MAUDE report 10781533 ↗
• 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 10781515 ↗
• 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 10781089 ↗
• 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 10781003 ↗
• 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 10780819 ↗
• 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 10780796 ↗
• 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 10780498 ↗
• MalfunctionNov 3, 2020Break; Break

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT A DISINFECTING AGENT WAS NOT USED AS PART OF THE DISINFECTION PROCESS. THE DISINFECTING PROCESS THAT WAS FOLLOWED WAS CLEAN WATER SHOWER PLUS HIGH TEMPERATURE AND HIGH PRESSURE DISINFECTION. THE PROCESS OF PUTTING LOOSE SCREWS INTO THE BOX WAS OPERATED BY THE WORKERS RESPONSIBLE FOR THE DISINFECTION IN THE HOSPITAL. IT WAS NOTED THAT THE TEMPERATURE WAS 134 DEGREES CELSIUS, AND THE PRESSURE WAS 3BAR.

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

  MAUDE report 10780490 ↗
• 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 10780356 ↗
• 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 10780279 ↗
• 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 10780208 ↗
• 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 10779065 ↗
• MalfunctionSep 9, 2020Break; 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 10508807 ↗
• MalfunctionMar 4, 2020Break; Break

  IT WAS REPORTED THAT DURING THE SURGERY, THE PLATE WAS BROKEN AND COULDN'T BE USED NORMALLY. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). 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 9788045 ↗
• MalfunctionMar 4, 2020Break; Break

  IT WAS REPORTED THAT DURING THE SURGERY, THE PLATE WAS BROKEN AND COULDN'T BE USED NORMALLY. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). 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 9788030 ↗