NA 03.111.007Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982072085), received between Mar 5, 2019 and Aug 21, 2019 — classified as 2 malfunctions.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionAug 21, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A POSITIONING SCREW FOR A VARIABLE ANGLE LOCKING COMPRESSION PLATE (LCP) TWO-COLUMN PLATE GUIDE BLOCK BROKE DURING INSERTION INTO THE GUIDE BLOCK. PROCEDURE OUTCOME IS UNKNOWN. NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICES: GUIDE BLOCK (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A POSITIONING SCREW FOR DISTAL RADIUS GUIDE BLOCK. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8915577 ↗
• MalfunctionMar 5, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SURGEON WAS UNABLE TO SCREW THE AIMING BLOCK FOR DISTAL RADIUS PLATE ONTO THE PLATE. THE ATTEMPT WAS MADE USING DIFFERENT PLATES. THE SURGEON SUGGESTED THAT THE SCREW MIGHT BE STRIPPED. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE: DISTAL RADIUS PLATE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR A POSITIONING SCREW FOR DISTAL RADIUS GUIDE BLOCK. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8391970 ↗