TSRH® Spinal System 830-043Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00673978050126), received between Mar 24, 2022 and Mar 24, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2022Break; Break

  INFORMATION WAS RECEIVED FROM THE REGULATORY BODY (RB) REGARDING A PATIENT IMPLANTED WITH A ROD IN A POSTERIOR SPINAL FUSION PROCEDURE FOR AN UNKNOWN SPINAL INDICATION. IT WAS REPORTED THAT UNDER FLUOROSCOPY IMAGING, PIN FROM THE ROD WAS IN THE PATIENT AND HAD BEEN PUSHED THROUGH THE BACK AND INTO THE CHEST CAVITY. THE ORTHO TEAM ATTEMPTED TO PULL AND RETRIEVE THE PIN BUT WERE UNSUCCESSFUL. THE ORTHO TEAM WENT AHEAD AND FINISHED THEIR PROCEDURE AND CLOSED THE PATIENT. THE PATIENT WAS REPOSITIONED SUPINE, REINTUBATED, AND THE GENERAL SURGERY TEAM PERFORMED THE ADDITIONAL UNPLANNED THORACOSCOPIC PROCEDURE TO REMOVE THE PIN. THE PATIENT ALSO HAD AN UNPLANNED TRANSFER TO THE PICU. IT IS UNKNOWN IF THERE WERE ANY PATIENT SYMPTOMS. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13889299 ↗