NA 498.236Recalls & reported problems
Synthes GmbH · 5.0MM TI HARD ROD 150MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034789606), received between Feb 1, 2019 and Feb 1, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
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
Device problems
- Break1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 1, 2019Break; Break
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A PEDIATRIC PATIENT UNDERWENT AN UNKNOWN PROCEDURE USING A UNIVERSAL SPINE SYSTEM (USS) SYSTEM ROD. ON AN UNKNOWN POSTOPERATIVE DATE, THE ROD BROKE IN THE PATIENT. REVISION SURGERY IS SCHEDULED FOR (B)(6) 2019. THERE ARE NO REPORTS OF SERIOUS/PERMANENT DAMAGE. THIS REPORT IS FOR A 5.0MM TITANIUM (TI) HARD ROD 150MM. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Code Available
MAUDE report 8297144 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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