S-ROM 53-6320Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295172819), received between Oct 12, 2017 and Feb 7, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Bent” (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.

• MalfunctionFeb 7, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT S-ROM TRIAL STEM BODY 20 IN QUESTION WAS OUT OF MIDLINE WHEN MATED WITH A NECK TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16311651 ↗
• MalfunctionJan 27, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, THE S-ROM TRIAL STEM BODY 18 IN QUESTION WAS OUT OF MIDLINE WHEN MATED WITH A NECK TRIAL. THE DEVICE HAD BEEN ORDERED FOR THE SURGERY DATED (B)(6) 2023 AND IT WAS BEFORE USE. THIS IS THE 2ND TIME THAT THIS EVENT OCCURRED AT THIS HOSPITAL. THE SAME KIND OF EVENT HAS BEEN REPORTED IN (B)(4). NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16252288 ↗
• MalfunctionJun 1, 2018Bent; Scratched Material; Bent; Scratched Material

  NEW REP AT (B)(6) MEDICAL CENTER. WENT THROUGH INSTRUMENT INVENTORY ON (B)(6) 2018, AND NOTICED A FEW INSTRUMENTS THAT WERE IN AN UNACCEPTABLE CONDITION. THIS INSTRUMENT WAS NOT USED DURING A SURGERY AND NO STAFF MEMBER HAD MENTIONED THE DAMAGE. THIS IS A SROM 20 PROXIMAL BODY (COLOR: BLUE).. THE GROVES WHERE THE NECK TRIAL SITS ARE DAMAGED ( BENT, CHIPPED). ASKING THAT THESE ARE REPLACED AND SHIPPED TO: (B)(6) MEDICAL CENTER, UNITED STATES. THE DAMAGED INSTRUMENTS WILL BE RETURNED TO (B)(4), LOT CODE: AH1105. P.S: ON THE COMPLAIN TOOL; YOU ARE UNABLE TO ADD THE LOT CODE.... THE PRODUCT WON'T ADD/UPLOAD WHEN THE LOT IS ALSO TYPED. PATIENT CONSEQUENCE? :NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7560339 ↗
• MalfunctionOct 12, 2017Bent; Bent

  COMPLAINT DESCRIPTION: IT WAS REPORTED THAT THE 20X15 PROXIMAL BODY WAS BENT DURING TRIALING. / / INVESTIGATION METHOD: / / INVESTIGATION SUMMARY:

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 6944622 ↗