S-ROM 2576-36-006Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295147060), received between Oct 4, 2017 and Aug 1, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 1, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SROM NECK TRIAL WILL NOT MAINTAIN ITS VERSION WHEN ATTACHED TO THE STEM TRIAL. NECK TRIAL JUST CONTINUES TO SPIN. IT WAS UNKNOWN ABOUT SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 17433983 ↗
• MalfunctionJan 4, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT NUT TIGHTENER WOULD NOT THREAD INTO NECK TRIAL BECAUSE OF A DEFORMITY. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16098283 ↗
• MalfunctionDec 27, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE 36+6 NECK TRIAL WILL NOT ENGAGE STEM TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16055374 ↗
• MalfunctionMar 7, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON WAS HAVING THE TECH PUT SOME NECK TRIALS ONTO STEM TRIALS AND HE WAS UNABLE TO GET THE 36 +6 NECK TRIAL TO CONNECT WITH OUT SPINNING. THEY REAMED BEYOND THIS SIZE SO IT WAS NO FACTOR IN THE CASE. AFTER THE INSTRUMENTS WERE CLEAN HE TRIED TO CONNECT THIS NECK TRIAL TO THE STEM TRIAL AND HE COULD NOT GET IT TO WORK. IT DID NOT AFFECT THE PATIENT BUT HE COULD NOT USE IT GOING FORWARD AND NEED IT REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13684887 ↗
• MalfunctionFeb 19, 2020Material Twisted/Bent; Naturally Worn; Scratched Material; Illegible Information; Material Twisted/Bent; Naturally Worn; Scratched Material; Illegible Information

  IT WAS REPORTED THAT THE INSTRUMENT WERE DIFFICULT OR IMPOSSIBLE TO READ ETCHING DUE TO WEAR AND TEAR OVER THE YEARS. THE SURGEON IS CONCERNED ABOUT THE PATIENT SAFETY ISSUE AND THE INSTRUMENTS NEED TO BE REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9729089 ↗
• MalfunctionFeb 14, 2018Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT INNER THREADS OF NECK TRIAL ARE STRIPPED AND WILL NOT ENGAGE WITH STEM TRIAL FOR SROM. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7269837 ↗
• MalfunctionOct 4, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DER STATES THAT THE STERILE PROCESSING CALLED THE REP TO COME TO THEM AND SAID THEY COULD NOT GET THESE TWO INSTRUMENTS APART. THEY TRIED SOAKING THEM OVER THE WEEKEND BUT IT DID NOT WORK. ALSO TRIED TO PRY THEM OPEN, IT DID NOT WORK. DID NOT KNOW THEY WERE STUCK TOGETHER UNTIL TUESDAY (B)(6) AFTER THE LONG WEEKEND. IT WAS STATED THAT IT WAS NOT BROKEN BUT JAMMED TOGETHER.

  Patient problems: No Information

  MAUDE report 6914605 ↗