VERTEX® Reconstruction System 7755122Recalls & reported problems
Medtronic Sofamor Danek, Inc. · ROD 7755122 3.5/3.2mm ADJUSTABLE · Class 2 · Implant
All models of VERTEX Reconstruction System (34)
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 00613994302823), received between Sep 19, 2017 and Sep 19, 2017 — classified as 2 injuries.
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
- Migration or Expulsion of Device1
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 19, 2017Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT OCCIPITAL AND POSTERIOR CERVICAL FUSION AT OC-C3 DUE TO NON-UNION ON (B)(6) 2017. POST-OP, A REVISION WAS PERFORMED DUE TO LOOSE CONNECTOR. A SECOND REVISION WAS PLANNED AS THE ROD AT THE HINGED END OF THE CONNECTOR LOOKED TO HAVE BROKEN ON ONE SIDE AND THE OTHER SIDE, THE ROD LOOKED TO HAVE SLID OUT OF THE CONNECTION TO THE OCCIPITAL PLATE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6875059 ↗InjurySep 19, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT THE PATIENT UNDERWENT OCCIPITAL AND POSTERIOR CERVICAL FUSION AT OC-C3 DUE TO NON-UNION ON (B)(6) 2017. POST-OP, A REVISION WAS PERFORMED DUE TO LOOSE CONNECTOR. A SECOND REVISION WAS PLANNED AS THE ROD AT THE HINGED END OF THE CONNECTOR LOOKED TO HAVE BROKEN ON ONE SIDE AND THE OTHER SIDE, THE ROD LOOKED TO HAVE SLID OUT OF THE CONNECTION TO THE OCCIPITAL PLATE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6875058 ↗
Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices
- EXPEDIUM 179702000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL439 reports
- EXPEDIUM VERSE 199721001Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL227 reports
- XIA 3 48230000Stryker Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL193 reports
- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
- NA 04.614.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL80 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- Arsenal Deformity Spinal Fixation System 47127Alphatec Spine, Inc. · APPLIANCE, FIXATION, SPINAL INTERLAMINAL66 reports
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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