TSRH® Spinal System 828-083Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00673978048680), received between Nov 9, 2017 and Nov 4, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A REGULATORY BODY REGARDING A DEVICE USED FOR NON-CERVICAL SPINE POSTERIOR PEDICLE FIXATION IN A SKELETALLY MATURE PATIENT. IT WAS REPORTED THAT AFTER 9 DAYS OF PAIN AND WEAKNESS OF BOTH LOWER EXTREMITIES DUE TO HEAVY OBJECTS HITTING THE LOWER BACK, THE PATIENT WAS ADMITTED TO OUR HOSPITAL FOR TREATMENT ON (B)(6) 2020. ON (B)(6) 2020, THE PATIENT UNDERWENT "OPEN REDUCTION, FUSION AND INTERNAL FIXATION OF LUMBAR 3 VERTEBRAL FRACTURES + POSTERIOR DECOMPRESSION OF SPINAL CANAL". A TOTAL OF 8 SCREWS, 8 NUTS AND 1 TITANIUM ALLOY ROD WERE IMPLANTED DURING THE SURGERY. THE SURGERY WENT WELL AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2021. ON (B)(6) 2022, THE PATIENT'S RE-EXAMINATION CT IN OUR HOSPITAL SHOWED THAT THE TITANIUM ROD WAS BROKEN. ON (B)(6) 2022, THE PATIENT WAS ADMITTED TO (B)(6) FOR TREATMENT. ON (B)(6) 2022, THE PATIENT UNDERWENT "POSTERIOR LUMBAR DECOMPRESSION, BONE GRAFTING AND INTERNAL FIXATION", AND THE BROKEN ROD WAS TAKEN OUT SUCCESSFULLY. ON (B)(6) 2022, THE PATIENT WAS DISCHARGED FROM HOSPITAL. THIS PRODUCT NEEDED TO BE DISINFECTED BEFORE USE, AND HAD NO EXPIRATION DATE. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15733415 ↗
• InjuryJan 8, 2021Break; Break

  INFORMATION WAS RECEIVED FIELD REPRESENTATIVE REGARDING PATIENT WITH POSTERIOR INSTRUMENTED ARTHRODESE T12 S1 FOR A DEGENERATIVE DISCOPATHY INVOLVED IN SYNTHESIS AND REPLACEMENT. LEVELS IMPLANTED - T12 S1. IT WAS REPORTED DURING NORMAL USE, PATIENT REPORTED THAT IN (B)(6) HE PERCEIVED A LOUD DEAF NOISE IN HIS BACK AND SEVERE PAIN ON THE DAY OF HOSPITALIZATION. RX TESTS WERE CARRIED OUT AND THE 2 RODS WERE FOUND TO BE BROKEN. THE 2 BROKEN RODS AND THEIR INTACT SCREWS HAVE BEEN REMOVED AND REPLACED. EVEN IF THE BARS HAD BEEN INTACT THEY WOULD HAVE REPLACED THEM EQUALLY. THERE WAS NO BROKEN FRAGMENTS LEFT IN THE PATIENT. PATIENT IS ALIVE - NO INJURY. ON 2020-JAN-04, RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO MALFUNCTION WITH THE REPORTED BONE SCREWS. PATIENT WAS NOT HOSPITALIZED PROLONG AS A RESULT OF THE EVENT. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. THERE WERE NO COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. PROCEDURE WAS COMPLETED IN PATIENT WITHOUT PROBLEM. CUSTOMER REFUSED TO RETURN THE PRODUCT AS THEY INTENDED TO KEEP IT.

  Patient problems: Pain

  MAUDE report 11138902 ↗
• InjuryNov 9, 2017Break; Break

  PROCEDURE: LUMBAR POSTERIOR FUSION IT WAS REPORTED THAT THE PATIENT UNDERWENT OCCIPITO-CERVICAL FUSION SURGERY. POST-OP, LESS THAN 1 MONTH AFTER SURGERY, THE LEFT JOINT ROD RUPTURED AND BROKE. NO FUSION OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7015589 ↗