NA 400.835ERecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10887587045450), received between Sep 24, 2018 and Apr 8, 2022 — classified as 4 injuries, 4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CHINA AS FOLLOWS: IT WAS REPORTED THAT DURING A SKULL REPAIR SURGERY ON MARCH 11, 2022, A SCREW BROKE INTRAOPERATIVELY DURING INSERTION. THREE (3) ADDITIONAL SCREWS WERE USED WITH BREAKAGE OCCURRING EACH TIME. NO FRAGMENTS REMAINED BEHIND IN THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO SURGICAL DELAY WAS REPORTED. THIS IS REPORT 3 OF 4 FOR (B)(4). THIS REPORT IS FOR A NEURO SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14058854 ↗
• InjuryApr 8, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A SKULL REPAIR SURGERY ON (B)(6) 2022, A SCREW BROKE INTRAOPERATIVELY DURING INSERTION. THREE (3) ADDITIONAL SCREWS WERE USED WITH BREAKAGE OCCURRING EACH TIME. NO FRAGMENTS REMAINED BEHIND IN THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO SURGICAL DELAY WAS REPORTED. THIS IS REPORT 4 OF 4 FOR (B)(4). THIS REPORT IS FOR A NEURO SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14058840 ↗
• InjuryApr 8, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A SKULL REPAIR SURGERY ON (B)(6), 2022, A SCREW BROKE INTRAOPERATIVELY DURING INSERTION. THREE (3) ADDITIONAL SCREWS WERE USED WITH BREAKAGE OCCURRING EACH TIME. NO FRAGMENTS REMAINED BEHIND IN THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO SURGICAL DELAY WAS REPORTED. THIS IS REPORT 2 OF 4 FOR (B)(4). THIS REPORT IS FOR A NEURO SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14058205 ↗
• InjuryApr 8, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A SKULL REPAIR SURGERY ON (B)(6), 2022, A SCREW BROKE INTRAOPERATIVELY DURING INSERTION. THREE (3) ADDITIONAL SCREWS WERE USED WITH BREAKAGE OCCURRING EACH TIME. NO FRAGMENTS REMAINED BEHIND IN THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO SURGICAL DELAY WAS REPORTED. THIS IS REPORT 1 OF 4 FOR (B)(4). THIS REPORT IS FOR A NEURO SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14056767 ↗
• MalfunctionOct 29, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2020, THE SURGEON OBSERVED THE TITANIUM LOW PROFILE NEURO SCREW SELF DRILLING DID NOT HAVE GOOD BONE PURCHASE AND MAY BREAK. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR A TITANIUM (TI) LOW PROFILE NEURO SCREW SELF-DRILLING 5MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10757152 ↗
• MalfunctionSep 24, 2018Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT A CRANIOTOMY FOR BONE FLAP REPLACEMENT ON AN UNKNOWN DATE. DURING THE PROCEDURE, WHILE THREE (3) OF THE LOW PROFILE NEURO SCREWS WERE BEING IMPLANTED, THE HEAD OF THE SCREW BROKE OFF. THE SCREW SHAFT REMAINS EMBEDDED IN THE PATIENT¿S BONE. IT IS UNKNOWN IF PROCEDURE WAS DELAYED DUE TO THE DEVICE BREAKAGE. THIS REPORT IS FOR ONE (1) LOW PROFILE NEURO SCREW. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7904387 ↗
• MalfunctionSep 24, 2018Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT A CRANIOTOMY FOR BONE FLAP REPLACEMENT ON AN UNKNOWN DATE. DURING THE PROCEDURE, WHILE THREE (3) OF THE LOW PROFILE NEURO SCREWS WERE BEING IMPLANTED, THE HEAD OF THE SCREW BROKE OFF. THE SCREW SHAFT REMAINS EMBEDDED IN THE PATIENT¿S BONE. IT IS UNKNOWN IF PROCEDURE WAS DELAYED DUE TO THE DEVICE BREAKAGE. THIS REPORT IS FOR ONE (1) LOW PROFILE NEURO SCREW . THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7904382 ↗
• MalfunctionSep 24, 2018Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT A CRANIOTOMY FOR BONE FLAP REPLACEMENT ON AN UNKNOWN DATE. DURING THE PROCEDURE, WHILE THREE (3) OF THE LOW PROFILE NEURO SCREWS WERE BEING IMPLANTED, THE HEAD OF THE SCREW BROKE OFF. THE SCREW SHAFT REMAINS EMBEDDED IN THE PATIENT¿S BONE. IT IS UNKNOWN IF PROCEDURE WAS DELAYED DUE TO THE DEVICE BREAKAGE. THIS REPORT IS FOR ONE (1) LOW PROFILE NEURO SCREW. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7904380 ↗