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PRESTIGE® LP Cervical Disc System 6973246Recalls & reported problems

Medtronic Sofamor Danek, Inc. · TRIAL 6973246 IMPLANT · Class 3

All models of PRESTIGE LP Cervical Disc System (11)

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 00613994490445), received between Jul 31, 2018 and Jul 31, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Degraded” (1 report).

1 other recall cover devices cleared under the same FDA submission (P090029); they may or may not involve this specific model.

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

  • Adverse Event Without Identified Device or Use Problem1
  • Degraded1

Patient problems

  • Failure of Implant1
  • Pain1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 31, 2018Degraded; Adverse Event Without Identified Device or Use Problem; Degraded

    IT WAS REPORTED THAT POST OPERATIVELY THE PATIENT FAILED CONSERVATIVE CARE OF PAIN SYMPTOMS DUE TO POSTERIOR OSTEOPHYTE. THE PATIENT UNDERWENT EXPLANATION OF THE IMPLANT AND THE PREVIOUS ARTHROPLASTY WAS CONVERTED TO FUSION. THE IMPLANT WAS REMOVED EASILY WITH NO DAMAGE DONE TO THE IMPLANT OR PATIENTS ANATOMY.

    Patient problems: Failure of Implant; Pain

    MAUDE report 7734231 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P090029. One submission often covers many models, so check the product and lot details in each record.

  • Z-1641-2018 · Mar 13, 2018 · Terminated
    Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES: a) REF 6975205, 5mm b) REF 6975206, 6mm c) REF 6975207, 7mm Product Usage: The PRESTIGE

Other PROSTHESIS, INTERVERTEBRAL DISC devices

All PROSTHESIS, INTERVERTEBRAL DISC devices →

Sources and updates

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