PRESTIGE® LP Cervical Disc System 6972870Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994493620), received between Jun 17, 2019 and Aug 29, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (2 reports).

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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 29, 2025Inadequacy of Device Shape and/or Size; Migration; Inadequacy of Device Shape and/or Size; Migration

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING AN EVENT WHICH OCCURRED POST A CLINICAL STUDY (STUDY ID: (B)(4) SPINAL FUSION PROCEDURE IN A PATIENT (PATIENT ID: (B)(6). PATIENT MEDICAL HISTORY: ARTHRITIS, HYPERLIPIDEMIA, HYPERTENSION IT WAS REPORTED THAT, POST CRANIAL SPINE SURGERY C6-C7, AS PER INVESTIGATOR ASSESSMENT IT WAS CONFIRMED THAT IMPLANTED DEVICES DOES NOT APPEAR STABLE AND SECURE. THE PATIENT EXPERIENCED EVIDENCE OF IMPLANT SUBSIDENCE POSTOPERATIVELY. THE EVENT IS SUSPECTED TO BE DEVICE-RELATED DUE TO ANATOMICAL AND BIOMECHANICAL MISMATCH. THE PATIENT IS APPROXIMATELY 7 FEET TALL, AND THE LARGEST AVAILABLE IMPLANT WAS USED; HOWEVER, IT DID NOT PROVIDE FULL ENDPLATE COVERAGE AND RESULTED IN AN ANTERIOR SHIFT OF THE CENTRE OF ROTATION. THIS SUBOPTIMAL IMPLANT POSITIONING AND SIZE MAY HAVE CONTRIBUTED TO INCREASED AXIAL LOAD CONCENTRATION AND INADEQUATE LOAD DISTRIBUTION ACROSS THE ENDPLATE, LEADING TO IMPLANT SETTLING OR SINKING (SUBSIDENCE) INTO THE VERTEBRAL BODY. THE SUBSIDENCE WAS NOT IMMEDIATELY EVIDENT INTRAOPERATIVELY BUT WAS LATER CONFIRMED ON FOLLOW-UP IMAGING OBTAINED AT THE 1-MONTH FOL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22920420 ↗
• InjuryJul 6, 2020Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN UNKNOWN INDICATION IN NEED C6-7 ARTHROPLASTY USED IN SPINAL THERAPY. IT WAS REPORTED THAT THE IMPLANT RECESSED POSTERIOR A LITTLE BIT AFTER SOME TIME. THE PATIENT PRESENTED NEW SYMPTOMS AND THE SURGEON DETERMINED AND EXPLANT THE DEVICE. THE DEVICE WAS REPLACED. THERE WERE NO FRAGMENTS IN THE PATIENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Stenosis; Therapeutic Effects, Unexpected

  MAUDE report 10231334 ↗
• InjuryJun 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRE-OPERATIVE DIAGNOSIS (IMPLANT SURGERY): MYELORADICULOPATHY TREATED LEVEL: C6-C7 REASON FOR EXPLANTATION: PERSISTENT PAIN SURGICAL SITE DESCRIPTION: SCAR TISSUE WAS PRESENT, INTEGRITY OF DEVICE WAS INTACT. IN THE REVISION SURGERY, FUSION WAS PERFORMED WITH PLATE AND INTERBODY.

  Patient problems: Inadequate Pain Relief; Neck Pain

  MAUDE report 8703863 ↗

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