VERTEX® Reconstruction System 7002526Recalls & reported problems
Medtronic Sofamor Danek, Inc. · CROSSLINK 7002526 ADJ CROSSLINK MED · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885074175058), received between Jan 22, 2020 and Jun 3, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 3, 2021Break; Break
INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A CROSSLINK USED FOR SPINAL SURGERY. PRE-OP DIAGNOSIS WAS THORACIC SPINAL STENOSIS. PROCEDURE PERFORMED WAS THORACIC SPINAL CANAL ENLARGEMENT DECOMPRESSION AND NERVE ROOT CANAL DECOMPRESSION. IT WAS REPORTED THAT INTRA-OPERATIVELY, VERTEX MAX CROSSLINK WAS BROKEN. THE CROSSLINK WAS DISCONNECTED FROM THE MIDDLE DURING THE IMPLANTATION PROCESS AND COULD NOT BE USED. THE PRODUCT CAME IN CONTACT WITH PATIENT. THERE WAS NO FRAGMENT OF THE IMPLANT OR INSTRUMENT REMAINING IN THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WAS NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11931209 ↗MalfunctionJan 22, 2020Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR CERVICAL CANAL DILATATION DUE TO CERVICAL SPINAL STENOSIS. INTRA-OPERATIVELY, THE INSTRUMENT BROKE. NO FRAGMENT OF THE INSTRUMENT REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATION OCCURRED AS A RESULT OF THE ALLEGED EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9614732 ↗
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
- 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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