NA 498.142Recalls & reported problems
Synthes GmbH · 6.0MM TI CURVED SOFT ROD 75MM · Class 2 · Implant
Data updated Oct 13, 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 10705034789026), received between Mar 24, 2017 and Mar 24, 2017 — classified as 2 injuries.
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
- Failure of Implant2
- Impaired Healing2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 24, 2017Break; Break
IT WAS REPORTED THAT TWO (2) 6.0MM TITANIUM CURVED SOFT RODS 75MM BROKE. THE PATIENT HAD A CLICK-X IMPLANT IN 2005 AND HAD ALL HARDWARE REMOVED (6 SCREWS, 2 RODS) DUE TO NON-FUSION ON (B)(6) 2017. DURING THE PROCEDURE IT WAS NOTED VIA X-RAY FILMS THAT TWO (2) RODS WERE BROKEN AT THE SAME NON-UNION L4-L5 LEVEL. NO IMPLANT WAS REPLACED. THERE WAS NO SURGICAL DELAY AND THE BROKEN PIECES WERE REMOVED EASILY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM. CONCOMITANT MEDICAL PRODUCTS: SCREW (PART UNKNOWN, LOT UNKNOWN, QUANTITY 6). THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: Failure of Implant; Impaired Healing
MAUDE report 6431189 ↗InjuryMar 24, 2017Break; Break
IT WAS REPORTED THAT TWO (2) 6.0MM TITANIUM CURVED SOFT RODS 75MM BROKE. THE PATIENT HAD A CLICK-X IMPLANT IN 2005 AND HAD ALL HARDWARE REMOVED (6 SCREWS, 2 RODS) DUE TO NON-FUSION ON (B)(6) 2017. DURING THE PROCEDURE IT WAS NOTED VIA X-RAY FILMS THAT TWO (2) RODS WERE BROKEN AT THE SAME NON-UNION L4-L5 LEVEL. NO IMPLANT WAS REPLACED. THERE WAS NO SURGICAL DELAY AND THE BROKEN PIECES WERE REMOVED EASILY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM. CONCOMITANT MEDICAL PRODUCTS: SCREW (PART UNKNOWN, LOT UNKNOWN, QUANTITY 6). THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: Failure of Implant; Impaired Healing
MAUDE report 6431183 ↗
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- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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