S-ROM 2576-15-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295146346), received between Jul 21, 2017 and Apr 11, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THESE PRODUCT HAD REACHED END OF LIFE DUE TO WEAR AND TEAR. THE SURGEONS COMPLAINED THAT INSTRUMENTS WERE DULL, ILLEGIBLE, AND GENERALLY WORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24845929 ↗
• MalfunctionApr 19, 2023Corroded; Corroded

  DEVICES APPEAR RUSTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16767561 ↗
• MalfunctionSep 21, 2021Naturally Worn; Naturally Worn

  QUESTION: 1. WAS SURGERY TIME EXTENDED? IF YES, WHAT IS THE DURATION OF THE DELAY?" ANSWER: ON (B)(6) 2021 ADDITIONAL INFORMATION (2) : "SURGERY TIME WAS NOT EXTENDED." ON (B)(6) 2021 ADDITIONAL INFORMATION (3) : "SURGERY TIME WAS ONLY USED EXTENDED 2 MIN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12510958 ↗
• MalfunctionFeb 20, 2020Illegible Information; Illegible Information

  IT WAS REPORTED THAT SROM INSTRUMENTS ARE DIFFICULT OR IMPOSSIBLE TO READ THE SIZING. SURGEON IS CONCERNED THIS IS A PATIENT SAFETY ISSUE AND INSTRUMENTS SHOULD BE REPLACED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9734656 ↗
• MalfunctionJul 2, 2019Device-Device Incompatibility; Material Deformation; Material Twisted/Bent; Scratched Material; Device-Device Incompatibility; Material Deformation; Material Twisted/Bent; Scratched Material

  ADDITIONAL INFORMATION RECEIVED INDICATING THAT THE FEATURE THAT WAS WORN AND NOT MAKING IT FUNCTION AS INTENDED WAS THE TOP PORTION THAT ACCEPTS THE NECK SEGMENT DOES NOT FUNCTION CORRECTLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8753993 ↗
• MalfunctionMay 20, 2019Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED INDICATING THAT NO BROKEN PIECES WERE LEFT IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8624797 ↗
• MalfunctionFeb 8, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TRIAL NECK WAS NO LONGER ATTACHED TO THE STEM TRIAL. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8323532 ↗
• MalfunctionAug 21, 2018Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THE TRIAL 15MM STEM AND THE 36+8 NECK SEGMENT ARE BOTH STRIPPED AND WOULD NOT ENGAGE. THE STEM/SLEEVE WEDGES DAMAGED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7802402 ↗
• MalfunctionJul 11, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE NECK TRIAL WOULD NOT SECURELY FIT ON THE STEM TRIAL. NECK TRIAL WOULD SPIN AROUND ON THE STEM TRIAL. NO SURGICAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7676922 ↗
• MalfunctionJul 21, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE THREADS ON STEM TRIALS ARE DAMAGED. IT WAS ALSO STATED THAT THE NECK TRIALS DO NOT LOCK DOWN EASY.

  Patient problems: No Information

  MAUDE report 6731174 ↗