PRESTIGE LP™ 6973050Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994714831), received between Sep 2, 2020 and Mar 11, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (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.

• MalfunctionMar 11, 2026Degraded; Mechanical Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A DEVICE USED FOR ARTHRO PLASTY SPINAL THERAPY. IT WAS REPORTED THAT THE INSTRUMENTS ARE WORN AND INSERTER DIDN'T ATTACH SECURELY TO THE IMPLANT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24566802 ↗
• MalfunctionFeb 17, 2026Break; Mechanical Problem

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING THE DEVICES USED FOR CERVICAL ARTHROPLASTY P ROCEDURE. IT WAS REPORTED THAT THERE WAS A LOSS OF ELASTICITY IN THE INSERTER SHAFT, RESULTING IN INABILITY TO GRAB THE IMPLANT, AND SLIGHT DAMAGE TO ONE OF THE BLADES OF THE RAIL PUNCH, CAUSING ISSUES WHEN CREATING KEELS IN THE VERTEBRAE. INSTRUMENT BREAKAGE WAS IDENTIFIED FOR BOTH THE INSERTER SHAFT AND RAIL PUNCH. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24361502 ↗
• MalfunctionSep 2, 2020Failure to Align; Deformation Due to Compressive Stress; Failure to Align; Deformation Due to Compressive Stress

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING CERVICAL DISC REPLACEMENT (LEVEL 5/6) DUE TO CERVICAL ARTHROPLASTY IT WAS REPORTED THAT THE INSERTER SHAFT WAS COMPRESSED AND WOULD NOT ALIGN WITH THE IMPLANT AND IMPLANT COULD NOT ATTACH TO INSERTER. AN INSTRUMENT WAS THEN USED TO PRY THE INNER SHAFT TO ITS INTENDED CONFIGURATION, IT THEN ATTACHED TO THE IMPLANT. THE FIRST IMPLANT WAS DAMAGED WHILE UNCOVERING THE PROBLEM SO ANOTHER ONE WAS USED. THE INSTRUMENTS WERE DISCARDED BY CUSTOMER AND WILL NOT BE RETURNED. THERE WERE NO PATIENT SYMPTOMS/COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED.

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

  MAUDE report 10481932 ↗

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