NA 388.907Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034773865), received between Nov 12, 2021 and Sep 27, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (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 18, 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.

• MalfunctionSep 27, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023 DURING AN UNKNOWN PROCEDURE, THE ROD TEMPLATES IN QUESTION BROKE DURING USE. THERE WAS NO ADVERSE PATIENT IMPACT. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO ADDITIONAL INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 5.0MM COATED ROD TEMPLATE 500MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17829511 ↗
• MalfunctionSep 27, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023 DURING AN UNKNOWN PROCEDURE, THE ROD TEMPLATES IN QUESTION BROKE DURING USE. THERE WAS NO ADVERSE PATIENT IMPACT. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO ADDITIONAL INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 5.0MM COATED ROD TEMPLATE 500MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17829399 ↗
• MalfunctionNov 12, 2021Material Integrity Problem; No Apparent Adverse Event; Material Integrity Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2021, THE COATED ROD TEMPLATE WAS FOUND TO BE BROKEN DURING THE REVERSE LOGISTICS AUDIT OF THE RETURNED DEVICE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE (1) 5.0MM COATED ROD TEMPLATE 500MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12804158 ↗