VERTEX® Reconstruction System 7755278Recalls & reported problems
Medtronic Sofamor Danek, Inc. · PLATE 7755278 Adjustable OC · Class 2 · Implant
All models of VERTEX Reconstruction System (34)
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 00613994387011), received between Nov 16, 2021 and Nov 16, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH PRE-OP DIAGNOSIS- CHIN ON CHEST DEFORMITY INVOLVED IN THE POSTERIOR CERVICAL FUSION. ADDITION OF OCCIPITAL PLATE AND RODS TO EXISTING IMPLANT CONSTRUCT. LEVELS IM PLANTED- OCCIPUT TO T2. IT WAS REPORTED THAT POST-OPERATIVELY, THE OCCIPITAL ROD MECHANISM "FELL APART" SHORTLY AFTER SURGERY ON (B)(6) 2017. THEY DECIDED TO TREAT THE PATIENT WITH A HALO DEVICE RATHER THAN ANOTHER SURGERY TO REPLACE FAILED IMPLANTS. THE PATIENT EVENTUALLY HAD DIFFICULTY LOOKING STRAIGHT AHEAD, SO THEY SCHEDULED A REVISION OF THE OCCIPITAL RODS AND CORRECTION OF THE SAGITTAL DEFORMITY. THE PATIENT INCURRED A VASCULAR INJURY DURING THE REVISION ON (B)(6) 2021 AND THEY WERE UNABLE TO COMPLETE THE SURGERY. ON (B)(6) 2021, RECEIVED ADDITIONAL INFORMATION THAT PATIENT HAD SUFFERED A MAJOR STROKE. IT HAS ALSO BEEN REPORTED TO THAT PATIENT HAD PASSED AROUND 6PM ON (B)(6) 2021. ON 2021-OCT-27, RECEIVED ADDITIONAL INFORMATION THAT AS PER A/P X-RAY IMAGE ON (B)(6) 2017, THE HINGE OF THE ROD ON THE RIGHT WAS DISCONNECTED. ON THE LATERAL X-RAY IMAGE OF (B)(6) 2017 THE PROXIMAL EXTENSION OF THE ROD THAT CONNECTS TO TH
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12818001 ↗
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- 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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