PRESTIGE® LP Cervical Disc System 6972670Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994493651), received between Feb 13, 2017 and Jun 22, 2018 — classified as 2 injuries.

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 18, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryJun 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH FORAMINAL STENOSIS/LEFT SIDED RADICULOPATHY C5-6 AND UNDERWENT CERVICAL ARTHROPLASTY AT C5-6. POST-OP, IT IS UNKNOWN IF THE PRODUCT CAUSED ANY ISSUES AS IT APPEARED WELL PLACED AND INTEGRATED IN THE ENDPLATES. UPON REMOVAL, HETEROTOPIC OSSIFICATION AND BRIDGING FUSION BONE OVER THE TOP OF THE IMPLANT WAS NOTICED, CLEARLY LIMITING ITS PURPOSE. ALSO, BONE AND SOFT TISSUE WAS POSTERIOR TO THE IMPLANT NEAR THE FORAMEN. PATIENT IS HAVING PAIN IN LEFT ARM WITH EXTENSION OF NECK AND AS A RESULT OF THIS ADDITIONAL POSTERIOR CERVICAL FORAMINOTOMY WAS PERFORMED.

  Patient problems: Extraskeletal ossification; Pain

  MAUDE report 7628624 ↗
• InjuryFeb 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2015, PATIENT UNDERWENT STANDARD ONE LEVEL CERVICAL DISC ARTHROPLASTY AT LEVEL C4-5, DUE TO PRE-OP DIAGNOSIS AS NECK PAIN WHERE PATIENT WAS IMPLANTED WITH AN ARTIFICIAL CERVICAL DISC AT C4/C5. REPORTEDLY, POST-OP, PATIENT CONTINUED TO HAVE NECK PAIN. SURGEON EXPLAINED THAT THIS WAS A WORKMAN'S COMP CASE AND THE IMPLANT WAS POSITIONED PROPERLY AND DID NOT APPEAR TO HAVE FAILED IN ANY WAY. THE REMOVAL OF THE IMPLANT AND FUSION OF THIS LEVEL WAS PLANNED AS A RESULT OF THIS EVENT. ON (B)(6) 2017, THE ARTIFICIAL CERVICAL DISC WAS REMOVED AT C4/C5. REMOVAL OF THE DISC WAS UNCOMPLICATED.

  Patient problems: Neck Pain; No Code Available

  MAUDE report 6325132 ↗

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