NA 04.600.014Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034734118), received between Jul 15, 2021 and Jul 15, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Integrity Problem” (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 16, 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.

• InjuryJul 15, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT REVISION SURGERY DUE TO TWO BROKEN TITANIUM PRECON RODS. INITIALLY, THE PATIENT HAD A T6 TO ILIUM POSTERIOR SPINE FUSION ON AN UNKNOWN DATE IN 2016. AT AN UNKNOWN POINT IN TIME, THE PATIENT BILATERALLY BROKE BOTH RODS. IT IS UNKNOWN HOW IT WAS DISCOVERED. THE ROD WAS BROKEN AT THE L3 AND L4 LEVEL. THE SURGEON THEN CONTOURED NEW RODS AND RECONNECTED THEM TO THE EXISTING SCREWS FROM T6-ILIUM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 6.0 TI PRECON ROD 50MM STR LEN/400MM THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12172821 ↗
• InjuryJul 15, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT REVISION SURGERY DUE TO TWO BROKEN TITANIUM PRECON RODS. INITIALLY, THE PATIENT HAD A T6 TO ILIUM POSTERIOR SPINE FUSION ON AN UNKNOWN DATE IN 2016. AT AN UNKNOWN POINT IN TIME, THE PATIENT BILATERALLY BROKE BOTH RODS. IT IS UNKNOWN HOW IT WAS DISCOVERED. THE ROD WAS BROKEN AT THE L3 AND L4 LEVEL. THE SURGEON THEN CONTOURED NEW RODS AND RECONNECTED THEM TO THE EXISTING SCREWS FROM T6-ILIUM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR (1) 6.0 TI PRECON ROD 50MM STR LEN/400MM THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12172777 ↗