VERTEX® Reconstruction System 7752536Recalls & reported problems
Medtronic Sofamor Danek, Inc. · CROSSLINK 7752536 MEDIUM ROD · 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 00613994239273), received between Mar 29, 2019 and Mar 29, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (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
- Migration or Expulsion of Device1
Patient problems
- Discomfort1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 29, 2019Migration or Expulsion of Device; Migration or Expulsion of Device
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 AND ALSO THE ROD CROSSLINK'S CENTER HEX WAS ALSO LOOSENED. 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 8463257 ↗
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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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