NA 04.633.191Recalls & reported problems
Synthes GmbH · 4.0MM/5.5MM TI TAPERED ROD 500MM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034746388), received between Nov 20, 2019 and Nov 20, 2019 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (4 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
Device problems
- Break4
Patient problems
- No Patient Involvement4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 20, 2019Break; Break
IT WAS REPORTED THAT ON (B)(6) 2019, THE FOUR (4) TITANIUM TAPERED ROD WAS FOUND TO BE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 4.0MM/5.5MM TI TAPERED ROD 500MM. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9350414 ↗MalfunctionNov 20, 2019Break; Break
IT WAS REPORTED THAT ON (B)(6) 2019, THE FOUR (4) TITANIUM TAPERED ROD WAS FOUND TO BE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 4.0MM/5.5MM TI TAPERED ROD 500MM. THIS IS REPORT 3 OF 4 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9350395 ↗MalfunctionNov 20, 2019Break; Break
IT WAS REPORTED THAT ON (B)(6) 2019, THE FOUR (4) TITANIUM TAPERED ROD WAS FOUND TO BE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 4.0MM/5.5MM TI TAPERED ROD 500MM. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9349861 ↗MalfunctionNov 20, 2019Break; Break
IT WAS REPORTED THAT ON (B)(6) 2019, THE FOUR (4) TITANIUM TAPERED ROD WAS FOUND TO BE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 4.0MM/5.5MM TI TAPERED ROD 500MM. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9349357 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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