NA 498.158Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705034789095), received between Oct 31, 2019 and Jun 17, 2020 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, FOUR (4) 240MM TITANIUM (TI) ROD, ONE (1) 500MM TITANIUM (TI) ROD, THREE (3) 80MM TITANIUM (TI) CURVED ROD, ONE (1) 500MM TITANIUM (TI) SOFT ROD AND ONE (1) 40MM TITANIUM (TI) CURVED ROD WAS BROKEN DURING REVERSE LOGISTICS AUDIT OF THE RETURNED DEVICES AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 4 OF 10 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10162534 ↗
• MalfunctionJun 16, 2020Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  IT WAS REPORTED THAT THE THREE (3) 6.0MM TITANIUM SOFT ROD 500MM, FIVE (5) 3.5MM TITANIUM ROD 240MM, ONE (1) 3.5MM TITANIUM CURVED ROD 80MM, AND ONE (1) 3.5MM TITANIUM CURVED ROD 40MM WERE FOUND BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICES. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 6.0MM TI SOFT ROD 500MM. THIS IS REPORT 4 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 10159886 ↗
• MalfunctionJun 16, 2020Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  IT WAS REPORTED THAT THE THREE (3) 6.0MM TITANIUM SOFT ROD 500MM, FIVE (5) 3.5MM TITANIUM ROD 240MM, ONE (1) 3.5MM TITANIUM CURVED ROD 80MM, AND ONE (1) 3.5MM TITANIUM CURVED ROD 40MM WERE FOUND BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICES. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 6.0MM TI SOFT ROD 500MM. THIS IS REPORT 3 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 10159867 ↗
• MalfunctionJun 16, 2020Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  IT WAS REPORTED THAT THE THREE (3) 6.0MM TITANIUM SOFT ROD 500MM, FIVE (5) 3.5MM TITANIUM ROD 240MM, ONE (1) 3.5MM TITANIUM CURVED ROD 80MM, AND ONE (1) 3.5MM TITANIUM CURVED ROD 40MM WERE FOUND BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICES. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 6.0MM TI SOFT ROD 500MM. THIS IS REPORT 1 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 10159827 ↗
• MalfunctionOct 31, 2019Break; Break

  LIBERTAS: IT WAS REPORTED ON (B)(6) 2019, THE 6.0MM TITANIUM SOFT ROD 500MM WAS BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9263630 ↗
• MalfunctionOct 31, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, TWO (2) TITANIUM (TI) SOFT RODS AND ONE (1) UNKNOWN ROD WERE NOTED TO BE BROKEN DURING LOGISTICS AUDIT OF THE RETURNED DEVICES AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9260022 ↗
• MalfunctionOct 31, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, TWO (2) TITANIUM (TI) SOFT RODS AND ONE (1) UNKNOWN ROD WERE NOTED TO BE BROKEN DURING LOGISTICS AUDIT OF THE RETURNED DEVICES AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9259915 ↗