NA 498.296Recalls & reported problems
Synthes GmbH · 6.0MM TI ROD 500MM · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034789989), received between Sep 3, 2019 and Jun 17, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break2
Patient problems
- No Patient Involvement2
Recent adverse event reports
The 2 most recent of 2 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 6 OF 10 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 10162710 ↗MalfunctionSep 3, 2019Break; Break
LIBERTAS: IT WAS REPORTED THAT ON (B)(6) 2019, THE ROD WAS FOUND 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 8956968 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.