NA 04.636.065Recalls & reported problems
Synthes GmbH · 5.5MM TI CURVED ROD 65MM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034748672), received between Mar 8, 2019 and Mar 8, 2019 — classified as 2 injuries.
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
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- No Code Available2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A POSTERIOR LUMBAR FUSION REVISION SURGERY TO EXTEND THE CONSTRUCT 1 LEVEL UP FOR ADJACENT LEVEL DISEASE AT L4-L5. THE CONSTRUCT WAS S1-L5 AND WAS EXTENDED UP TO L4-S1. TWO (2) 6.0MM TITANIUM MATRIX SCREW, TWO (2) 5.5MM TITANIUM CURVED ROD, TWO (2) TITANIUM MATRIX LOCKING CAP, AND TWO (2) TITANIUM MATRIX TOP LOADING POLYAXIAL HEAD WERE THE DEVICES IMPLANTED AT L4, THE SITE OF THE ADJACENT LEVEL DISEASE AT L4-L5. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A 5.5MM TI CURVED ROD 65MM. THIS IS REPORT 4 OF 8 FOR (B)(4).
Patient problems: No Code Available
MAUDE report 8405027 ↗InjuryMar 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A POSTERIOR LUMBAR FUSION REVISION SURGERY TO EXTEND THE CONSTRUCT 1 LEVEL UP FOR ADJACENT LEVEL DISEASE AT L4-L5. THE CONSTRUCT WAS S1-L5 AND WAS EXTENDED UP TO L4-S1. TWO (2) 6.0MM TITANIUM MATRIX SCREW, TWO (2) 5.5MM TITANIUM CURVED ROD, TWO (2) TITANIUM MATRIX LOCKING CAP, AND TWO (2) TITANIUM MATRIX TOP LOADING POLYAXIAL HEAD WERE THE DEVICES IMPLANTED AT L4, THE SITE OF THE ADJACENT LEVEL DISEASE AT L4-L5. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A 5.5MM TI CURVED ROD 65MM. THIS IS REPORT 3 OF 8 FOR (B)(4).
Patient problems: No Code Available
MAUDE report 8404953 ↗
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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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