S-ROM 53-6330Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295172840), received between Aug 8, 2019 and Nov 23, 2022 — classified as 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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 23, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE ACTIS SIZE 6 BROACH TRIAL POST BROKE OFF DURING SURGERY. IT WAS NOTICED UNDER FLUOROSCOPY THAT THE FEMORAL NECK TRIAL WASN¿T SEATED CORRECTLY. AFTER TRIALING THE NECK AND HEAD TRIAL WERE REMOVED AND THE POST BROKE OFF BEFORE A BROACH HANDLE COULD BE ATTACHED. THERE WAS A SURGICAL DELAY OF 45 MINUTES TO REMOVE THE TRIAL BROACH.

  Patient problems: Insufficient Information

  MAUDE report 15851215 ↗
• MalfunctionAug 8, 2019Break; Device-Device Incompatibility; Material Deformation; Break; Device-Device Incompatibility; Material Deformation

  THE TRIALS AND THEIR TEETH WERE BROKEN TO THE POINT THAT A SOLID CONSTRUCT COULD NOT BE ASSEMBLED. IN YESTERDAY¿S PROCEDURE WITH THE SAME KIT, THIS WAS NOT AN ISSUE. TODAY, THIS WAS AN ISSUE FROM THE START. NOT SURE WHEN THIS HAPPENED. NO DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8873450 ↗