S-ROM 2576-20-130Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295146797), received between Apr 18, 2018 and Mar 23, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2026Illegible Information

  IT WAS REPORTED THAT THE TOPS OF THE SLEEVE TRIALS HAVE THE SIZES SCRAPED OFF. THIS DID NOT OCCUR INTRAOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24665626 ↗
• MalfunctionAug 23, 2021Material Integrity Problem; Material Integrity Problem

  INSTRUMENTS DAMAGED FROM PREVIOUS SROM CASES. FOUND TO BE DAMAGED AT THE CASE. X2 DAMAGED SLEEVE TRIALS NEED REPLACING -DAMAGED. X1 11X16 STEM TRIAL NEEDS REPLACING -DAMAGED. X1 PLASTIC FRAME SLEEVE NEEDS REPLACING -IS LOST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12356530 ↗
• MalfunctionApr 6, 2020Illegible Information; Illegible Information

  IT WAS REPORTED THAT THE SROM SLEEVES ARE DAMAGED AND CAN¿T BE READ. NO LOT NUMBERS CAN BE READ. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9928313 ↗
• MalfunctionJun 19, 2019Material Discolored; Material Deformation; Material Twisted/Bent; Naturally Worn; Scratched Material; Material Discolored; Material Deformation; Material Twisted/Bent; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT THE OFFICE SETS INSTRUMENT WAS WORN AND CANNOT READ. NO SURGERY WAS AFFECTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8711529 ↗
• MalfunctionMar 29, 2019Material Discolored; Material Deformation; Naturally Worn; Material Discolored; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT THE OFFICE SETS CANNOT READ THE NUMBERS. IT WAS WORN OUT. DID NOT EFFECT A SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8466461 ↗
• MalfunctionApr 18, 2018Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE SROM SLEEVES HAVE BECOME WORN FROM SAWING AND NEED REPLACEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7439671 ↗