NA 498.120Recalls & reported problems
Synthes GmbH · 3.5MM TI ROD 80MM · Class 2 · Implant
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10705034788951), received between Jan 28, 2020 and Jan 28, 2020 — classified as 15 malfunctions.
The most frequently reported specific device problem is “Break” (15 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
Device problems
- Break15
Patient problems
- No Patient Involvement15
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 28, 2020Break; Break
LIBERTAS: IT WAS REPORTED ON (B)(6) 2019, THAT TEN (10) 3.5MM TITANIUM ROD BROKE DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR ONE (1) 3.5MM TI ROD 80MM. THIS REPORT IS 9 OF 10 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9639798 ↗MalfunctionJan 28, 2020Break; Break
LIBERTAS: IT WAS REPORTED ON (B)(6) 2019, THAT TEN (10) 3.5MM TITANIUM ROD BROKE DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR ONE (1) 3.5MM TI ROD 80MM. THIS REPORT IS 4 OF 10 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9639787 ↗MalfunctionJan 28, 2020Break; Break
LIBERTAS: IT WAS REPORTED ON (B)(6) 2019, THAT TEN (10) 3.5MM TITANIUM ROD BROKE DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR ONE (1) 3.5MM TI ROD 80MM. THIS REPORT IS 5 OF 10 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9639770 ↗MalfunctionJan 28, 2020Break; Break
LIBERTAS: IT WAS REPORTED ON (B)(6) 2019, THAT TEN (10) 3.5MM TITANIUM ROD BROKE DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR ONE (1) 3.5MM TI ROD 350MM. THIS REPORT IS 8 OF 10 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9639765 ↗MalfunctionJan 28, 2020Break; Break
"LIBERTAS": IT WAS REPORTED ON (B)(6) 2019, THAT TEN (10) 3.5MM TITANIUM ROD BROKE DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR ONE (1) 3.5MM TI ROD 80MM. THIS REPORT IS 7 OF 10 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9639754 ↗MalfunctionJan 28, 2020Break; Break
LIBERTAS: IT WAS REPORTED ON (B)(6) 2019, THAT TEN (10) 3.5MM TITANIUM ROD BROKE DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR ONE (1) 3.5MM TI ROD 80MM. THIS REPORT IS 3 OF 10 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9639751 ↗MalfunctionJan 28, 2020Break; Break
LIBERTAS: IT WAS REPORTED ON (B)(6) 2019, THAT TEN (10) 3.5MM TITANIUM ROD BROKE DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR ONE (1) 3.5MM TI ROD 80MM. THIS REPORT IS 6 OF 10 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9639749 ↗MalfunctionJan 28, 2020Break; Break
LIBERTAS: IT WAS REPORTED ON (B)(6) 2019, THAT TEN (10) 3.5MM TITANIUM ROD BROKE DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR ONE (1) 3.5MM TI ROD 80MM. THIS REPORT IS 4 OF 10 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9639748 ↗MalfunctionJan 28, 2020Break; Break
(B)(6): IT WAS REPORTED ON (B)(6) 2019, THAT TEN (10) 3.5MM TITANIUM ROD BROKE DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT (B)(6). THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR ONE (1) 3.5MM TI ROD 80MM. THIS REPORT IS 7 OF 10 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9639747 ↗MalfunctionJan 28, 2020Break; Break
LIBERTAS: IT WAS REPORTED ON (B)(6) 2019, THAT TEN (10) 3.5MM TITANIUM ROD BROKE DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR ONE (1) 3.5MM TI ROD 80MM. THIS REPORT IS 3 OF 10 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9639746 ↗MalfunctionJan 28, 2020Break; Break
LIBERTAS: IT WAS REPORTED ON (B)(6) 2019, THAT TEN (10) 3.5MM TITANIUM ROD BROKE DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR ONE (1) 3.5MM TI ROD 80MM. THIS REPORT IS 5 OF 10 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9639742 ↗MalfunctionJan 28, 2020Break; Break
LIBERTAS: IT WAS REPORTED ON (B)(6) 2019, THAT TEN (10) 3.5MM TITANIUM ROD BROKE DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR ONE (1) 3.5MM TI ROD 80MM. THIS REPORT IS 10 OF 10 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9639740 ↗MalfunctionJan 28, 2020Break; Break
LIBERTAS: IT WAS REPORTED ON (B)(6) 2019, THAT TEN (10) 3.5MM TITANIUM ROD BROKE DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR ONE (1) 3.5MM TI ROD 80MM. THIS REPORT IS 9 OF 10 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9639734 ↗MalfunctionJan 28, 2020Break; Break
LIBERTAS: IT WAS REPORTED ON (B)(6) 2019, THAT TEN (10) 3.5MM TITANIUM ROD BROKE DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR ONE (1) 3.5MM TI ROD 80MM. THIS REPORT IS 8 OF 10 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9639730 ↗MalfunctionJan 28, 2020Break; Break
LIBERTAS: IT WAS REPORTED ON (B)(6) 2019, THAT TEN (10) 3.5MM TITANIUM ROD BROKE DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR ONE (1) 3.5MM TI ROD 80MM. THIS REPORT IS 1 OF 10 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9639707 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.