NA 400.834Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 20887587045402), received between Jul 25, 2018 and Sep 11, 2025 — classified as 25 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Break” (29 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2025Break; Break

  IT WAS REPORTED THAT DURING THE MENINGIOMA RESECTION SURGERY, WHEN INSERTING THE SCREW, THE SCREW WAS BROKEN. ALL THE PIECES WERE REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23030705 ↗
• MalfunctionJul 31, 2025Break; Break

  IT WAS REPORTED DURING A EXCISION OF SADDLE AREA OCCUPYING LESION SURGERY, WHEN INSERTING THE SCREW, THE SCREW BROKE. SURGEON CHANGED TO ANOTHER SCREW TO CONTINUE THE SURGERY; THE SAME PROBLEM HAPPENED 3 ADDITIONAL TIMES. ALL THE PIECES WERE REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22675201 ↗
• MalfunctionJul 31, 2025Break; Break

  IT WAS REPORTED DURING A EXCISION OF SADDLE AREA OCCUPYING LESION SURGERY, WHEN INSERTING THE SCREW, THE SCREW BROKE. SURGEON CHANGED TO ANOTHER SCREW TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED 3 ADDITIONAL TIMES. ALL THE PIECES WERE REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22674994 ↗
• MalfunctionJul 31, 2025Break; Break

  IT WAS REPORTED DURING A EXCISION OF SADDLE AREA OCCUPYING LESION SURGERY, WHEN INSERTING THE SCREW, THE SCREW BROKE. SURGEON CHANGED TO ANOTHER SCREW TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED 3 ADDITIONAL TIMES. ALL THE PIECES WERE REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22674951 ↗
• MalfunctionJul 31, 2025Break; Break

  IT WAS REPORTED DURING A EXCISION OF SADDLE AREA OCCUPYING LESION SURGERY, WHEN INSERTING THE SCREW, THE SCREW BROKE. SURGEON CHANGED TO ANOTHER SCREW TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED 3 ADDITIONAL TIMES. ALL THE PIECES WERE REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22674749 ↗
• MalfunctionJul 31, 2025Break; Break

  IT WAS REPORTED THAT DURING A INTRACRANIAL HEMATOMA EVACUATION SURGERY, WHEN INSERT THE SCREW, THE SCREW WAS BROKE. SURGEON CHANGED TO ANOTHER SCREW TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED 3 ADDITIONAL TIMES. ALL THE PIECES WERE REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22674374 ↗
• MalfunctionJul 31, 2025Break; Break

  IT WAS REPORTED THAT DURING A INTRACRANIAL HEMATOMA EVACUATION SURGERY, WHEN INSERT THE SCREW, THE SCREW WAS BROKE. SURGEON CHANGED TO ANOTHER SCREW TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED 3 ADDITIONAL TIMES. ALL THE PIECES WERE REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22674362 ↗
• MalfunctionJul 31, 2025Break; Break

  IT WAS REPORTED THAT DURING A INTRACRANIAL HEMATOMA EVACUATION SURGERY, WHEN INSERT THE SCREW, THE SCREW WAS BROKE. SURGEON CHANGED TO ANOTHER SCREW TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED 3 ADDITIONAL TIMES. ALL THE PIECES WERE REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22674332 ↗
• MalfunctionJul 31, 2025Break; Break

  IT WAS REPORTED THAT DURING A INTRACRANIAL HEMATOMA EVACUATION SURGERY, WHEN INSERT THE SCREW, THE SCREW WAS BROKE. SURGEON CHANGED TO ANOTHER SCREW TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED 3 ADDITIONAL TIMES. ALL THE PIECES WERE REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22674238 ↗
• MalfunctionJul 8, 2025Break; Break

  IT WAS REPORTED THAT DURING THE SURGERY, THE SCREW WAS BROKEN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO OTHER MEDICAL INTERVENTION WAS REQUIRED, AND NO FRAGMENTS WERE RETAINED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22439855 ↗
• MalfunctionJul 8, 2025Break; Break

  IT WAS REPORTED THAT DURING THE SURGERY, WHEN INSERT THE SCREW, THE SCREW WAS BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22438458 ↗
• MalfunctionJun 11, 2025Break; Entrapment of Device; Break; Entrapment of Device

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WAS NO OTHER MEDICAL INTERVENTION REQUIRED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22189053 ↗
• MalfunctionDec 30, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21037306 ↗
• MalfunctionOct 28, 2024Break; Break

  IT WAS REPORTED THAT DURING THE SURGERY, WHEN INSERTING THE SCREW, THE SCREW BROKE. ALL THE PIECES WERE REMOVED FROM THE PATIENT. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20545250 ↗
• MalfunctionOct 28, 2024Break; Break

  IT WAS REPORTED THAT DURING THE SURGERY, WHEN INSERTING THE SCREW, THE SCREW BROKE. ALL THE PIECES WERE REMOVED FROM THE PATIENT. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20545166 ↗
• MalfunctionJun 28, 2024Break; Break

  SCREW BREAKAGE. IT WAS REPORTED THAT DURING THE SURGERY, ON (B)(6) 2024, WHEN INSERTING THE SCREW, THE SCREW BROKE. ALL THE PIECES WERE REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THIS REPORT IS FOR ONE TI LOW PROFILE NEURO SCREW SELF-DRILLING 4MM THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19632048 ↗
• MalfunctionMar 7, 2024Break; Break

  DEVICE REPORT FROM CHINA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024 DURING SURGERY, THE SCREW IN QUESTION BROKE. THE EVENT OCCURRED WHILE INSERTING THE SCREW. ALL PIECES WERE REMOVED WITH NO ADDITIONAL MEDICAL INTERVENTION. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE WITH NO SURGICAL DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES, THE PATIENT IS IN STABLE CONDITION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TI LOW PROFILE NEURO SCREW SELF-DRILLING 4MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18857674 ↗
• MalfunctionJan 31, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  DEVICE REPORT FROM CHINA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, A SCREW BROKE. THIS OCCURRED WHEN INSERTING THE SCREW. IT COULD NOT BE UNSCREWED FROM THE PEEK IMPLANT, AND ANOTHER SCREW WAS USED IN ADJACENT POSITIONS TO COMPLETE THE SURGERY. PROCEDURE WAS COMPLETED WITH NO DELAY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THIS REPORT IS FOR A TI LOW PROFILE NEURO SCREW SELF-DRILLING 4MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18614761 ↗
• InjuryDec 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM CHINA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT IN QUESTION HAD A CRANIOPLASTY PROCEDURE ON (B)(6) 2018. DURING A RECENT EXAMINATION IN (B)(6) OF 2023, IT WAS DISCOVERED THAT THE TITANIUM MESH USED DURING THE SURGERY HAD BEEN FRACTURED. THIS RESULTED IN DAMAGE TO THE SCALP AND EXPOSURE OF THE IMPLANT. AS A RESULT, A REVISION PROCEDURE WAS DEEMED NECESSARY BUT HAS NOT BEEN SCHEDULED YET. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TI LOW PROFILE NEURO SCREW SELF-DRILLING 4MM. THIS IS REPORT 10 OF 10 FOR (B)(4).

  Patient problems: Confusion/ Disorientation; Unspecified Tissue Injury

  MAUDE report 18310456 ↗
• InjuryDec 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM CHINA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT IN QUESTION HAD A CRANIOPLASTY PROCEDURE ON (B)(6) 2018. DURING A RECENT EXAMINATION IN NOVEMBER OF 2023, IT WAS DISCOVERED THAT THE TITANIUM MESH USED DURING THE SURGERY HAD BEEN FRACTURED. THIS RESULTED IN DAMAGE TO THE SCALP AND EXPOSURE OF THE IMPLANT. AS A RESULT, A REVISION PROCEDURE WAS DEEMED NECESSARY BUT HAS NOT BEEN SCHEDULED YET. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TI LOW PROFILE NEURO SCREW SELF-DRILLING 4MM. THIS IS REPORT 9 OF 10 FOR (B)(4).

  Patient problems: Confusion/ Disorientation; Unspecified Tissue Injury

  MAUDE report 18310454 ↗
• InjuryDec 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM CHINA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT IN QUESTION HAD A CRANIOPLASTY PROCEDURE ON (B)(6) 2018. DURING A RECENT EXAMINATION IN (B)(6) 2023, IT WAS DISCOVERED THAT THE TITANIUM MESH USED DURING THE SURGERY HAD BEEN FRACTURED. THIS RESULTED IN DAMAGE TO THE SCALP AND EXPOSURE OF THE IMPLANT. AS A RESULT, A REVISION PROCEDURE WAS DEEMED NECESSARY BUT HAS NOT BEEN SCHEDULED YET. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TI LOW PROFILE NEURO SCREW SELF-DRILLING 4MM. THIS IS REPORT 8 OF 10 FOR (B)(4).

  Patient problems: Confusion/ Disorientation; Unspecified Tissue Injury

  MAUDE report 18310453 ↗
• InjuryDec 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM CHINA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT IN QUESTION HAD A CRANIOPLASTY PROCEDURE ON (B)(6) 2018. DURING A RECENT EXAMINATION IN NOVEMBER OF 2023, IT WAS DISCOVERED THAT THE TITANIUM MESH USED DURING THE SURGERY HAD BEEN FRACTURED. THIS RESULTED IN DAMAGE TO THE SCALP AND EXPOSURE OF THE IMPLANT. AS A RESULT, A REVISION PROCEDURE WAS DEEMED NECESSARY BUT HAS NOT BEEN SCHEDULED YET. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TI LOW PROFILE NEURO SCREW SELF-DRILLING 4MM. THIS IS REPORT 7 OF 10 FOR (B)(4).

  Patient problems: Confusion/ Disorientation; Unspecified Tissue Injury

  MAUDE report 18310451 ↗
• InjuryDec 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM CHINA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT IN QUESTION HAD A CRANIOPLASTY PROCEDURE ON (B)(6) 2018. DURING A RECENT EXAMINATION IN (B)(6) OF 2023, IT WAS DISCOVERED THAT THE TITANIUM MESH USED DURING THE SURGERY HAD BEEN FRACTURED. THIS RESULTED IN DAMAGE TO THE SCALP AND EXPOSURE OF THE IMPLANT. AS A RESULT, A REVISION PROCEDURE WAS DEEMED NECESSARY BUT HAS NOT BEEN SCHEDULED YET. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TI LOW PROFILE NEURO SCREW SELF-DRILLING 4MM. THIS IS REPORT 6 OF 10 FOR (B)(4).

  Patient problems: Confusion/ Disorientation; Unspecified Tissue Injury

  MAUDE report 18310448 ↗
• InjuryDec 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM CHINA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT IN QUESTION HAD A CRANIOPLASTY PROCEDURE ON (B)(6) 2018. DURING A RECENT EXAMINATION IN (B)(6) 2023, IT WAS DISCOVERED THAT THE TITANIUM MESH USED DURING THE SURGERY HAD BEEN FRACTURED. THIS RESULTED IN DAMAGE TO THE SCALP AND EXPOSURE OF THE IMPLANT. AS A RESULT, A REVISION PROCEDURE WAS DEEMED NECESSARY BUT HAS NOT BEEN SCHEDULED YET. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TI LOW PROFILE NEURO SCREW SELF-DRILLING 4MM. THIS IS REPORT 4 OF 10 FOR (B)(4).

  Patient problems: Confusion/ Disorientation; Unspecified Tissue Injury

  MAUDE report 18310447 ↗
• InjuryDec 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM CHINA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT IN QUESTION HAD A CRANIOPLASTY PROCEDURE ON (B)(6) 2018. DURING A RECENT EXAMINATION IN NOVEMBER OF 2023, IT WAS DISCOVERED THAT THE TITANIUM MESH USED DURING THE SURGERY HAD BEEN FRACTURED. THIS RESULTED IN DAMAGE TO THE SCALP AND EXPOSURE OF THE IMPLANT. AS A RESULT, A REVISION PROCEDURE WAS DEEMED NECESSARY BUT HAS NOT BEEN SCHEDULED YET. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TI LOW PROFILE NEURO SCREW SELF-DRILLING 4MM. THIS IS REPORT 5 OF 10 FOR (B)(4).

  Patient problems: Confusion/ Disorientation; Unspecified Tissue Injury

  MAUDE report 18310446 ↗