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CD HORIZON® SOLERA® VOYAGER™ Spinal System 54750016550Recalls & reported problems

Medtronic Sofamor Danek, Inc. · MAS 54750016550 4.75 EXT TAB CN 6.5X50 S · Class 2 · Implant

All models of CD HORIZON SOLERA VOYAGER Spinal System (60)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169501058), received between Aug 2, 2017 and Jan 3, 2022 — classified as 1 injury, 1 malfunction.

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 18, 2026.

Most reported problems

Device problems

  • Break1
  • Migration or Expulsion of Device1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Code Available1
  • Pain1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 3, 2022Break; Break

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TLIF FOR L4/5 SPONDYLOLISTHESIS. IT WAS REPORTED THAT AFTER DEPLOYMENT, AT FIRST, THE V4 SCREW WAS INSERTED INTO THE PEDICLE, BUT THE TAB WAS OBSTRUCTED DURING SUBSEQUENT OPERATION, SO THE TAB WAS BROKEN BEFORE ROD INSTALLATION. AT THAT TIME, THE TAB BREAKER WAS TOO DEEPLY INSERTED IN THE SCREW HEAD, SO IT WAS BENT AT THE MIDDLE OF THE THREAD WHERE THE SET SCREW IS INSERTED, NOT AT THE FOLD PART. THE PRODUCT CAME IN PATIENT CONTACT. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13140647 ↗
  • InjuryAug 2, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

    IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PATIENT UNDERWENT A POSTERIOR LUMBAR INTERBODY FUSION DUE TO LUMBAR SPINAL CANAL STENOSIS AT L4-5. POST-OP, THE SCREW PLACED AT LEFT SIDE OF L5 DEVIATED. PATIENT SUFFERED FROM LOW BACK PAIN AND UNDERWENT A REVISION SURGERY ON (B)(6) 2017 FOR RE-FIXATION OF THE SAME SCREW. SURGERY WAS COMPLETED WITHOUT ANY COMPLICATIONS.

    Patient problems: No Code Available; Pain

    MAUDE report 6759389 ↗

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Sources and updates

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