NA 498.118Recalls & reported problems
Synthes GmbH · 6.0MM TI HARD ROD 450MM · Class 2 · Implant
Data updated Oct 16, 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 10705034788937), received between Mar 19, 2018 and Mar 19, 2018 — 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 16, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- Failure of Implant1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 19, 2018Break; Break
IT WAS REPORTED THAT ON (B)(6) 2008, PATIENT HAD ORIGINAL SURGERY FOR T2-L2 POSTERIOR SPINAL FUSION THORACOLUMBAR SPINE WITH ALLOGRAFT AND INSTRUMENTATION. PRIOR TO THE SURGERY, WHICH INVOLVED THE FUSING OF MULTIPLE LEVELS OF THE SPINE AND A LARGE AMOUNT OF HARDWARE, THE PATIENT WAS ASSURED THAT THE HARDWARE WAS MADE OF TITANIUM, WHICH WAS UNBREAKABLE AND WOULD LAST FOREVER. THE USE OF THE TITANIUM HARDWARE, AND THE MANNER IN WHICH IT WAS DESCRIBED, WAS ONE OF THE PRIMARY REASONS PATIENT AGREED TO UNDERGO THE PROCEDURE. ON OR ABOUT (B)(6) 2015, PATIENT WAS IN EXTREME PAIN AND WENT TO THE EMERGENCY ROOM. IT WAS DISCOVERED SOME OF THE HARDWARE HAD FRACTURED AND WAS CAUSING PATIENT SEVERE SYMPTOMS. IT IS UNKNOWN IF THE PATIENT WAS REVISED. THERE IS NO MORE INFORMATION AT THIS TIME. FURTHER IT WAS REPORTED THAT RODS BROKE POSTOPERATIVELY. CONCOMITANT DEVICES REPORTED: TI DUAL-OPENING PEDICLE HOOK SIDE-FOR 6.0 MM RODS (PART # 499.278, LOT # UNKNOWN, QUANTITY 7), TI TRANSVERSE PROCESS HK/DUAL- OPENING SIDE/RT F/6.0 MM RODS (PART # 499.280, , LOT # UNKNOWN, QUANTITY 1), TI TRANSVERSE PROCESS HK/DUAL- OPENING SIDE/LT F/6.0 MM RODS (PART # 499.281, LOT # UNKNOWN, QUANTITY 1), TI LOW PROFILE
Patient problems: Failure of Implant; Pain
MAUDE report 7349046 ↗
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- XIA 3 48230000Stryker Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL193 reports
- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
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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 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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