Proximal Humeral Plate 21133-4Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 09120047297353), received between Aug 7, 2018 and Jan 9, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

1 other recall cover devices cleared under the same FDA submission (K051412); they may or may not involve this specific model.

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.

• MalfunctionJan 9, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT SCREWS BACKED OUT OF A PROXIMAL HUMERAL PLATE, 4-HOLE POSTOPERATIVELY. ORIGINAL IMPLANT DATE (B)(6) 2016. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2016.

  Patient problems: No Information

  MAUDE report 8230385 ↗
• MalfunctionJan 8, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT SCREWS BACKED OUT OF A PROXIMAL HUMERAL PLATE, 4-HOLE POSTOPERATIVELY. ORIGINAL IMPLANT DATE IN (B)(6) 2014. A REVISION SURGERY WAS PERFORMED ON AN UNKNOWN DATE.

  Patient problems: No Information

  MAUDE report 8225699 ↗
• MalfunctionJan 8, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT SCREWS BACKED OUT OF A PROXIMAL HUMERAL PLATE, 4-HOLE POSTOPERATIVELY. ORIGINAL IMPLANT DATE (B)(6) 2014. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2014.

  Patient problems: No Information

  MAUDE report 8225695 ↗
• MalfunctionAug 7, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT 6 MONTHS AFTER A PROXIMAL HUMERAL FRACTURE TREATED WITH A PROXIMAL HUMERAL PLATE THE LOCKING SCREWS GOT LOOSE. A REVISION SURGERY WAS PERFORMED AT AN UNKNOWN DATE AND THE PLATE AS WELL AS THE SCREWS WERE EXPLANTED AND FURTHERMORE TREATED WITH AN UNKNOWN DEVICE. THERE WAS NO DELAYS IN SURGERY.

  Patient problems: No Information

  MAUDE report 7756143 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051412. One submission often covers many models, so check the product and lot details in each record.

• Z-1594-2026 · Jan 23, 2026 · Open, Classified
  Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal Humeral Plate. Article Numbers: 211341-10, 211341-4, 211341-7, 21134-4, 21134-5, 211