NA 212.210Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982152176), received between May 9, 2018 and Sep 15, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50773857 ↗
• MalfunctionSep 15, 2026Device-Device Incompatibility

  It was reported that there was frequent issues getting 2.4mm locking screws to engage near cortex. Customer did not specify any particular screw length, but thinks it happens with all lengths that customer uses.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50773827 ↗
• InjuryMay 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS AGAINST USER FACILITY MEDWATCH (B)(4), THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION. THIS REPORT CAPTURES ONE 5.0 MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE RECESS 32 MM. THIS IS REPORT 8 OF 10 FOR (B)(4). THE OTHER SCREW IS BEING CAPTURED ON RELATED (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7497923 ↗