NA 237.94Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982161611), received between Jan 27, 2022 and Sep 11, 2024 — classified as 2 injuries.

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

• InjurySep 11, 2024Break; Break

  THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE DUA SUMMARIZES 64 PATIENTS THAT WERE IMPLANTED WITH ANGLED BLADE PLATES. IMPLANTATION WAS BETWEEN (B)(6) 2000 TO (B)(6) 2023 AT (B)(6). PATIENT NUMBER 9. PATIENT IS A 70-YEAR-OLD FEMALE. REASON FOR IMPLANTATION WAS FRACTURE FIXATION. POST OP COMPLICATION INCLUDED NONUNION OF HIP FRACTURE & BROKEN BLADE PLATE. TREATMENT/INTERVENTION INCLUDED REOPERATION (REVISION OF PREVIOUS). IMPLANT(S) INVOLVED: 237.94 - 95-DEGREE, 70MM BLADE PLATE X1.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 20192119 ↗
• InjuryJan 27, 2022Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2021 DUE TO INCOMPLETE UNION AND/OR TRAUMA RESULTING IN A FRACTURE OF THE BONE AND A BROKEN BLADE PLATE. THE SURGEON REMOVED THE BROKEN BLADE PLATE/SCREWS, CLEANED OUT THE FRACTURE SITE, AND INSERTED A TFNA NAIL AFTER REDUCING THE FRACTURE. IT IS UNKNOWN WHEN THE ORIGINAL SURGERY WAS PERFORMED. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) 95 DEG CONDYLAR PLATE 9 HOLES/70MM/156MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Bone Fracture(s); Nonunion/Delayed-union Bone Fracture

  MAUDE report 13366560 ↗