NA 238.66Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982161994), received between Dec 10, 2021 and Dec 10, 2021 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 10, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE. THIS WAS A NON UNION PROXIMAL FEMUR OSTEOTOMY FIXED WITH SYNTHES 130 DEGREE BLADE PLATE. IT WAS NOTED THAT THE PLATE WAS BROKEN DUE TO NON UNION. THERE WAS AN UNKNOWN SURGICAL DELAY. IT WAS UNKNOWN IF THE PROCEDURE WAS COMPLETED. PATIENT STATUS IS UNKNOWN. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) ANGL-BLADEPL 130° 6HO L104 BLADE80 SST. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12977155 ↗