PRESTIGE® LP Cervical Disc System 6973060Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00613994714848), received between Jan 13, 2020 and Aug 31, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Mechanical Problem; Material Twisted/Bent

  Information was received from multiple sources (Manufacturer Representative, Healthcare Provider) regarding a device used for cervic al arthroplasty Spinal therapy at C5/6. It was reported that the inserters had difficulty seating all four inserter dimples into the interbody. Three of four dimples could be seated, but a snug fit could not be achieved before tightening the locking knob to secure the implant. There was difficulty attaching and locking the implant, including tightening the locking knob. The inserter prongs or dimples were suspected to be bent or unaligned; however, no visible damage was confirmed. There was no patient involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50516719 ↗
• MalfunctionFeb 8, 2026Degraded; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) PROCEDURE AT LEVELS 5-7 FOR A PRE-OPERATIVE DIAGNOSIS OF HERNIATED NUCLEUS PULPOSUS. IT WAS REPORTED THAT THREE INSERTERS HAVE BEEN BROKEN AND NO LONGER ATTACHED TO THE IMPLANTS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THERE WAS AN INSTRUMENT INCOMPATIBILITY WHICH MIGHT BE DUE TO WEAR ISSUE AND NOT BREAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24288233 ↗
• MalfunctionNov 3, 2020Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) VIA THE MANUFACTURER REPRESENTATIVE REGARDING AN EVENT THAT OCCURRED DURING A SPINAL ADR PROCEDURE IN A PATIENT. IT WAS REPORTED THAT THE IMPLANT FELL OFF THE INSERTER. NO PATIENT INJURY / COMPLICATION WAS REPORTED. PRODUCT WILL BE RETURNED, AND IT WAS REPLACED WITH A MEDTRONIC PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10776562 ↗
• MalfunctionJan 13, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CERVICAL DISC ARTHROPLASTY AT C6-7 DUE TO DEGENERATIVE DISK DISEASE(DDD). INTRA OP, INSERTER DID NOT RETAIN THE IMPLANT PROPERLY WHEN IMPACTED WITH THE MALLET. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9579882 ↗

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