VERTEX® Reconstruction System 7750346Recalls & reported problems
Medtronic Sofamor Danek, Inc. · CONNECTOR 7750346 DMNO3.5 4.0 TO 3.5 4.0 · Class 2 · Implant
All models of VERTEX Reconstruction System (34)
Data updated Oct 18, 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 00613994244505), received between Mar 29, 2019 and Mar 29, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component2
Patient problems
- Discomfort2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 29, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
PROCEDURE: EXTENSION OF PREVIOUS CERVICAL FUSION LEVELS IMPLANTED: C1-T2 IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, FOLLOW UP X-RAYS OF PATIENT SHOWED THE AXIAL CONNECTOR HAD DISCONNECTED ON ONE SIDE. PATIENT UNDERWENT REVISION SURGERY FOR THE REPLACEMENT OF THE IMPLANT. DURING THE REVISION SURGERY, IT WAS ALSO DISCOVERED THAT BOTH CONNECTORS HAD SEPARATED FROM THE ORIGINAL CONSTRUCT. ALL THE MALFUNCTIONED IMPLANTS HAVE BEEN REMOVED DURING THE REVISION SURGERY AND SINGLE RODS CONSTRUCT HAVE BEEN IMPLANTED. PATIENT SUFFERED WITH UNSTABLE CERVICAL SPINE AS A RESULT OF THIS EVENT.
Patient problems: Discomfort
MAUDE report 8463247 ↗InjuryMar 29, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
PROCEDURE: EXTENSION OF PREVIOUS CERVICAL FUSION LEVELS IMPLANTED: C1-T2 IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, FOLLOW UP X-RAYS OF PATIENT SHOWED THE AXIAL CONNECTOR HAD DISCONNECTED ON ONE SIDE. PATIENT UNDERWENT REVISION SURGERY FOR THE REPLACEMENT OF THE IMPLANT. ALL THE MALFUNCTIONED IMPLANTS HAVE BEEN REMOVED DURING THE REVISION SURGERY AND SINGLE RODS CONSTRUCT HAVE BEEN IMPLANTED. PATIENT SUFFERED WITH UNSTABLE CERVICAL SPINE AS A RESULT OF THIS EVENT.
Patient problems: Discomfort
MAUDE report 8463243 ↗
Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices
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- 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
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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