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PRESTIGE® LP Cervical Disc System 6972470Recalls & reported problems

Medtronic Sofamor Danek, Inc. · PRESTIGE LP DISC 7X14MM · Class 3 · Implant

All models of PRESTIGE LP Cervical Disc System (11)

Data updated Oct 16, 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 00613994493699), received between Feb 13, 2019 and Dec 29, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 1 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Device Dislodged or Dislocated1
  • Migration or Expulsion of Device1

Patient problems

  • Pain2

Recent adverse event reports

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

  • InjuryDec 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SMITH ROBINSON TECHNIQUE TO IMPLANT PRESTIGE DISC AT THE LEVEL C6/7. IT WAS REPORTED THAT, SURGEON ORDERED AN X-RAY WHICH SHOWED THE DEVICE HAD ROTATED. THE PATIENT DEVELOPED PAIN AT THE LEVEL OF OPERATION MULTIPLE MONTHS AFTER POST OP. THE DEVICE WAS EXPLANTED AND PERFORMED ANTERIOR CERVICAL DISCECTOMY AND FUSION. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Patient problems: Pain

    MAUDE report 23905218 ↗
  • InjuryFeb 13, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

    IT WAS REPORTED THAT THE PATIENT UNDERWENT ARTHROPLASTY AT C5-6 DUE TO DEGENERATIVE DISC DISEASE. POST-OP, THE IMPLANTED DEVICE (GRAFT) HAD SUBSIDED INTO THE BODY OF C6 DUE TO CRUSHED BODY OF C6 AND END PLATE. THE PATIENT SUFFERED MUCH NECK PAIN DUE TO THIS AND UNDERWENT REMOVAL SURGERY. THE DEVICE WAS REMOVED AND THEN A CORPECTOMY WAS DONE AT C6.

    Patient problems: Pain

    MAUDE report 8334436 ↗

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

How reports and recalls are matched · Editorial policy · Report an error on this page