NA 04.211.034Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982119094), received between Sep 16, 2022 and Jun 12, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (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.

• 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 22194418 ↗
• InjurySep 16, 2022Migration; Migration

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. AFTER THE INITIAL SURGERY, TWO SCREWS CAME OUT ON AN UNKNOWN DATE, SO A REVISION SURGERY WAS SCHEDULED FOR AND PERFORMED ON (B)(6) 2022. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 34MM. THIS IS REPORT 6 OF 7 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15438176 ↗
• InjurySep 16, 2022Migration; Migration

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. AFTER THE INITIAL SURGERY, TWO SCREWS CAME OUT ON AN UNKNOWN DATE, SO A REVISION SURGERY WAS SCHEDULED FOR AND PERFORMED ON (B)(6) 2022. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 34MM. THIS IS REPORT 5 OF 7 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15438175 ↗
• InjurySep 16, 2022Migration; Migration

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. AFTER THE INITIAL SURGERY, TWO SCREWS CAME OUT ON AN UNKNOWN DATE, SO A REVISION SURGERY WAS SCHEDULED FOR AND PERFORMED ON (B)(6) 2022. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 34MM. THIS IS REPORT 4 OF 7 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15438168 ↗