NA 207.740Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982148506), received between Oct 31, 2018 and Sep 11, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Break; Entrapment of Device

  Patient problems: Foreign Body In Patient

  MAUDE report 50739003 ↗
• MalfunctionMay 9, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN UNKNOWN PROCEDURE, THE SCREW IN QUESTION BROKE DURING INSERTION. THE DISTAL PORTION OF THE SCREW REMAINS INSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 4.0MM CANNULATED SCREW LONG THREAD/40MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16896319 ↗
• MalfunctionJul 2, 2020Break; Crack; Break; Crack

  UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON WAS IMPLANTING 4.0 CANNULATED SCREW AND HEARD A POP SOUND. CHECKED SCREW PLACEMENT UNDER A FLUOROSCOPE AND SCREW WAS BROKEN AND SOME THREADS ON THE SCREW HAD UNRAVELED. SCREW POSSIBLY COULD HAVE COME IN CONTACT WITH ANOTHER SCREW ALREADY IMPLANTED. THE PROCEDURE OUTCOME AND PATIENT STATUS WERE UNKNOWN. CONCOMITANT DEVICE REPORTTED: UNKNOWN SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN SCREWDRIVER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10224251 ↗
• MalfunctionOct 31, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE CUSTOMER RECEIVED AN EMPTY PACKAGE OF A CANNULATED SCREW LONG THREAD. IT IS UNKNOWN IF WHEN WAS THE ISSUE DISCOVERED. THERE WAS NO PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) 4.0MM CANNULATED SCREW LONG THREAD/40MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8026319 ↗