PRESTIGE® LP Cervical Disc System 6972460Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00613994493705), received between Nov 15, 2016 and Dec 26, 2019 — classified as 6 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 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 9521577 ↗
• InjuryNov 8, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT UNDERWENT UNSPECIFIED SURGERY. POST-OP, THE PATIENT ALLEGED THAT THE "DEVICE WAS TOO BIG AND BROKE SEVERAL DISCS OR BONES AROUND THE DEVICE".A REVISION SURGERY WAS PERFORMED ON (B)(6) 2018 AS THE RESULT OF THE EVENT.

  Patient problems: Injury

  MAUDE report 8053167 ↗
• InjuryAug 17, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGERY AT C5/6 DUE TO STENOSIS AND RIGHT ARM PAIN. POST-OP, THE DEVICE BECAME LOOSE. THE PATIENT SUFFERED FROM LEFT ARM PAIN, TISSUE DISCOLORATION WAS ALSO OBSERVED. HENCE, A REVISION SURGERY WAS PERFORMED IN WHICH THE DEVICE WAS EXPLANTED.

  Patient problems: Pain

  MAUDE report 6799703 ↗
• InjuryAug 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ARTHOPLASTY DUE TO DISC HERNIATION. IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, PATIENT WAS HAVING PAIN DUE TO WHICH PATIENT UNDERWENT REVISION ON (B)(6) 2017. THE DISC WAS REMOVED AND THE LEVEL WAS FUSED. NO COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Code Available; Pain

  MAUDE report 6783837 ↗
• InjuryMay 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT DEMOGRAPHICS: HEIGHT- 5'9"; RACE- CAUCASIAN. PRE-OP DIAGNOSIS FOR INITIAL SURGERY: SPONDYLOSIS WITH FORAMINAL STENOSIS (ARM AND NECK PAIN) INITIAL SURGERY: INDEX SURGERY LEVEL IMPLANTED: C6/C7 REASON FOR REVISION SURGERY: DISLOCATION OF PERIPROSTHETIC TISSUE AT C6/C7 REVISION SURGERY: ACDF (ANTERIOR CERVICAL DISCECTOMY AND FUSION) AT C6/C7 IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, PATIENT SYMPTOMS OF NECK AND ARM PAIN DID NOT RESOLVE FOLLOWING THE INDEX SURGERY. HENCE, A REVISION SURGERY WAS PERFORMED TO REVISE THE IMPLANT WITH ACDF.

  Patient problems: Inadequate Pain Relief; No Code Available

  MAUDE report 6546886 ↗
• InjuryNov 15, 2016Adverse 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 SURGERY. POST-OP, PATIENT SUFFERED WITH RADICULOPATHY AND SURGEON SUSPECTS CONTINUED CERVICAL STENOSIS. FOLLOWING INITIAL IMPLANT, SYMPTOMS OF RIGHT ARM PAIN, NUMBNESS, TINGLING AND WEAKNESS PERSISTED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THE PRODUCT DIDN'T BREAK. ON (B)(6) 2016, PATIENT UNDERWENT REVISION SURGERY AT LEVELS C5/6 WITH PRIMARY DIAGNOSIS FOR REVISION SURGERY AS C5/6 RADICULOPATHY.

  Patient problems: Neuropathy; Numbness; Stenosis; Tingling; Weakness

  MAUDE report 6101351 ↗

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