PRESTIGE® LP Cervical Disc System 6972260Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994493736), received between Dec 26, 2019 and Dec 26, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Malposition of Device” (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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 26, 2019Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT PRESENTED WITH DEGENERATIVE DISC DISEASE AND STENOSIS; AND UNDERWENT A SURGERY AT C5-C6 AND C6-C7 USING DISCS, RODS, SCREWS AND PLATES. POST-OP,THE PATIENT HAD VOCAL CORD PARALYSIS. ACCORDING TO THE SURGEON, THE PATIENT WAS NOT IMPROVING WITH ARTHROPLASTY DEVICE. IT WAS ALSO ALLEGED BY THE PATIENT THAT THE DISC WAS INSTALLED WRONG. HENCE, ON (B)(6) 2019, A REVISION SURGERY WAS PERFORMED, IN WHICH THE SURGEON EXPLANTED THE DISCS; AND THE PROCEDURE WAS CONVERTED TO FUSION. DECOMPRESSION WAS ALSO PERFORMED DURING THIS SURGERY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED CURRENTLY.

  Patient problems: Paralysis

  MAUDE report 9521558 ↗

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