TSRH® Spinal System 811-323Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00673978042756), received between Oct 10, 2017 and Feb 18, 2026 — classified as 1 injury, 1 malfunction.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2026Break

  ACCORDING TO THE REPORTER, DURING A SOFT TISSUE SUTURING PROCEDURE, THE SUTURE BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24385102 ↗
• InjuryOct 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRE-OPERATIVE DIAGNOSIS: SPINAL STENOSIS IT WAS REPORTED THAT THE PATIENT UNDERWENT LAMINECTOMY WITH INSTRUMENTED FUSION AT L5-S1 IN (B)(6) 2002, SCREWS AND CROSSLINK WERE IMPLANTED IN THIS INITIAL SURGERY. POST-OP, THE PATIENT EXPERIENCED ADJACENT LEVEL DISEASE AT L4-5. ALSO, FUSION HAD OCCURRED AT L5-S1, SO THE PREVIOUS HARDWARE WAS REMOVED AND NEW PEDICLE SCREWS AND RODS WERE PLACED ON (B)(6) 2017. DURING REMOVAL SURGERY, THE DOCTOR NOTICED A PSEUDOMENINGOCELE (ABNORMAL COLLECTION OF CEREBROSPINAL FLUID - CSF) UNDERNEATH THE CROSSLINK. THE DURA WAS REPAIRED AND NEW HARDWARE WAS PLACED AT L4-L5.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 6933705 ↗