NA 02.214.107Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982055415), received between Apr 11, 2023 and Apr 11, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, THE SCREWS IN QUESTION WOULD NOT RETAIN ON THE T4 DRIVER. THE SCREWS WERE TESTED WITH MULTIPLE DIFFERENT DRIVERS, AND OTHER SCREWS WERE TESTED ACROSS MULTIPLE DIFFERENT VA LOCKING HAND SETS. THERE WAS NO REPORTED PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 1.5MM CORTEX SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 7MM. THIS IS REPORT 4 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16714480 ↗
• MalfunctionApr 11, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, THE SCREWS IN QUESTION WOULD NOT RETAIN ON THE T4 DRIVER. THE SCREWS WERE TESTED WITH MULTIPLE DIFFERENT DRIVERS, AND OTHER SCREWS WERE TESTED ACROSS MULTIPLE DIFFERENT VA LOCKING HAND SETS. THERE WAS NO REPORTED PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 1.5MM CORTEX SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 7MM. THIS IS REPORT 7 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16714479 ↗
• MalfunctionApr 11, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, THE SCREWS IN QUESTION WOULD NOT RETAIN ON THE T4 DRIVER. THE SCREWS WERE TESTED WITH MULTIPLE DIFFERENT DRIVERS, AND OTHER SCREWS WERE TESTED ACROSS MULTIPLE DIFFERENT VA LOCKING HAND SETS. THERE WAS NO REPORTED PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 1.5MM CORTEX SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 7MM. THIS IS REPORT 5 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16714478 ↗
• MalfunctionApr 11, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, THE SCREWS IN QUESTION WOULD NOT RETAIN ON THE T4 DRIVER. THE SCREWS WERE TESTED WITH MULTIPLE DIFFERENT DRIVERS, AND OTHER SCREWS WERE TESTED ACROSS MULTIPLE DIFFERENT VA LOCKING HAND SETS. THERE WAS NO REPORTED PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 1.5MM CORTEX SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 7MM. THIS IS REPORT 6 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16714477 ↗
• MalfunctionApr 11, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, THE SCREWS IN QUESTION WOULD NOT RETAIN ON THE T4 DRIVER. THE SCREWS WERE TESTED WITH MULTIPLE DIFFERENT DRIVERS, AND OTHER SCREWS WERE TESTED ACROSS MULTIPLE DIFFERENT VA LOCKING HAND SETS. THERE WAS NO REPORTED PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 1.5MM CORTEX SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 7MM. THIS IS REPORT 1 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16714474 ↗
• MalfunctionApr 11, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, THE SCREWS IN QUESTION WOULD NOT RETAIN ON THE T4 DRIVER. THE SCREWS WERE TESTED WITH MULTIPLE DIFFERENT DRIVERS, AND OTHER SCREWS WERE TESTED ACROSS MULTIPLE DIFFERENT VA LOCKING HAND SETS. THERE WAS NO REPORTED PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 1.5MM CORTEX SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 7MM. THIS IS REPORT 3 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16714472 ↗
• MalfunctionApr 11, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, THE SCREWS IN QUESTION WOULD NOT RETAIN ON THE T4 DRIVER. THE SCREWS WERE TESTED WITH MULTIPLE DIFFERENT DRIVERS, AND OTHER SCREWS WERE TESTED ACROSS MULTIPLE DIFFERENT VA LOCKING HAND SETS. THERE WAS NO REPORTED PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 1.5MM CORTEX SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 7MM. THIS IS REPORT 2 OF 7 FOR(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16714470 ↗