S-ROM 2576-20-105Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295146742), received between Apr 3, 2020 and Jan 11, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Illegible Information” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 11, 2024Material Deformation; Scratched Material; Material Deformation; Scratched Material

  THIS INSTRUMENT IS COMPOSED OF A 1 PART. THE ZT TRIAL SLEEVES HAVE A FEW DENTS WITH SHARP SCRATCHES. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18496033 ↗
• MalfunctionOct 12, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT IT APPEARS AS IF THE BOTTOM OF THE TRIAL IS WORN BECAUSE WHEN THEY WENT TO EXTRACT THE TRIAL, THE FOOT OF THE TRIAL EXTRACTOR WHICH IS BRAND NEW WOULD NOT CATCH THE BOTTOM OF THE TRIAL. IT IS ASSUMED THAT THE BOTTOM OF THE TRIAL IS JUST ROUNDED OFF. THE INSTRUMENT DID NOT BREAK INTO TWO PIECES. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15587094 ↗
• 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 9928310 ↗
• MalfunctionApr 3, 2020Illegible Information; Illegible Information

  IT WAS REPORTED THAT THE SROM SLEEVES CAN¿T BE READ OR USED OR DAMAGED. NOT USED IN A CASE. CAN¿T READ LOT NUMBERS SO DON¿T ASK FOR THEM. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9919365 ↗