NA 400.834ERecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10887587045429), received between Sep 14, 2018 and Nov 3, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, A SCREW BROKE OFF TO THE BONE IN THE PATIENT. THE TOP HEAD OF THE SCREW WAS RETRIEVED, THE OTHER HALF WAS LEFT IN THE PATIENT. THIS REPORT IS FOR A TI LOW PROFILE NEURO SCREW SELF-DRILLING 4MM. REPORT WAS ALSO PROVIDED TO SYNTHES BY FDA AS USER FACILITY REPORT (B)(4). A COPY IS ATTACHED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18065497 ↗
• MalfunctionSep 14, 2018Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A PATIENT UNDERWENT A CRANIOTOMY TUMOR RESECTION. AS THE SURGEON WAS IMPLANTING THE THREE (3) TI LOW PROFILE NEURO SCREW SELF-DRILLING, THE SCREW HEADS CAME OFF AND THE REMAINING PORTION OF THE SCREWS REMAINED IN THE PATIENT. SURGICAL PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7878216 ↗
• MalfunctionSep 14, 2018Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A PATIENT UNDERWENT A CRANIOTOMY TUMOR RESECTION. AS THE SURGEON WAS IMPLANTING THE THREE (3) TI LOW PROFILE NEURO SCREW SELF-DRILLING, THE SCREW HEADS CAME OFF AND THE REMAINING PORTION OF THE SCREWS REMAINED IN THE PATIENT. SURGICAL PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7878209 ↗
• MalfunctionSep 14, 2018Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A PATIENT UNDERWENT A CRANIOTOMY TUMOR RESECTION. AS THE SURGEON WAS IMPLANTING THE THREE (3) TI LOW PROFILE NEURO SCREW SELF-DRILLING, THE SCREW HEADS CAME OFF AND THE REMAINING PORTION OF THE SCREWS REMAINED IN THE PATIENT. SURGICAL PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7878203 ↗