NA 04.211.046Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982119155), received between Dec 14, 2023 and Jun 12, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2025Break; Break

  IT WAS REPORTED THE SURGEON NOTED THAT SOME METAL MATERIAL SHAVINGS CAME OUT WHEN HE INSERTED THE SCREWS INTRAOPERATIVELY. SURGERY DATE IS UNKNOWN. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY OR HOW THE PROCEDURE WAS COMPLETED. NO KNOWN PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22194005 ↗
• MalfunctionDec 14, 2023Improper or Incorrect Procedure or Method; Material Deformation; Improper or Incorrect Procedure or Method; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE VA LOCKING SCREW IN QUESTION. WHEN THE SCREW IN QUESTION WAS INSERTED INTO THE THIRD HOLE FROM THE DISTAL END OF THE VA-DHP WITH A POWER TOOL, AN UNUSUAL NOISE WAS HEARD. THE IMAGE SHOWED THAT THE SCREW IN QUESTION WAS INSERTED WITH A DEFLECTION. THE SALES REP GUESSED THAT THE SCREW MIGHT INTERFERE WITH ANOTHER SCREW. THE DIRECTION OF THE SCREW CHANGED, SO THAT THE SURGEON REMOVED THE SCREW. THE SCREW IN QUESTION WAS DEFORMED, AND IT WAS REPLACED WITH A SHORTER SCREW. HOWEVER, THE SCREW HOLE WAS BROKEN, AND TORQUE DID NOT WORK. THEREFORE, A LOW-PROFILE SCREW WAS USED FOR SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THERE WAS NO PROBLEM WITH IMPLANT FIXATION DUE TO THE USE OF AN ALTERNATIVE. THIS REPORT INVOLVES ONE 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 46MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18326359 ↗