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
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 · TerminatedMedtronic 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
- Prodisc C SK PDSM5Centinel Spine, LLC · Prosthesis, Intervertebral Disc2 recalls4 reports
- Simplify® Cervical Artificial DiscNuvasive, Inc. · Prosthesis, Intervertebral Disc1 recall12 reports
- Prodisc C 09.820.055SCentinel Spine, LLC · Prosthesis, Intervertebral Disc1 recall9 reports
- Simplify® Cervical Artificial DiscNuvasive, Inc. · Prosthesis, Intervertebral Disc1 recall4 reports
- Prodisc C SK PDSXL5Centinel Spine, LLC · Prosthesis, Intervertebral Disc1 recall3 reports
- Simplify® Cervical Artificial DiscNuvasive, Inc. · Prosthesis, Intervertebral Disc1 recall3 reports
- Simplify® Cervical Artificial DiscNuvasive, Inc. · Prosthesis, Intervertebral Disc1 recall3 reports
- Simplify® Cervical Artificial DiscNuvasive, Inc. · Prosthesis, Intervertebral Disc1 recall3 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 13, 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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