PRESTIGE® LP Cervical Disc System 6972860Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00613994493637), received between Oct 11, 2017 and Nov 14, 2023 — classified as 9 injuries.

The most frequently reported specific device problem is “Migration” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryNov 14, 2023Migration; Migration

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING DEVICE USED FOR CERVICAL FUSION. LEVELS: C5/6 IT WAS REPORTED THAT CAGE SETTLING OCCURRED. THE CAGE SETTLED A COUPLE MILLIMETERS INTO THE END PLATE OF THE VERTEBRAL BODIES. DUE TO THIS, THE SURGEON PERFORMED A ACDF USING CAGE AND PLATE. ADDITIONAL SURGERY WAS PERFORMED TO EXPLANT THE CAGE USING DISTRACTION AND KOCHER CLAMP. PATIENT HAD INFECTION. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18128725 ↗
• InjuryDec 30, 2022Material Fragmentation; Mechanical Problem; Material Fragmentation; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR UNKNOWN INDICATION. IT WAS REPORTED THAT TWO PRESTIGE LP DISC EXPLANTED. PRODUCTS WILL BE RETURNED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT C6 COLLAPSED AND A CORPECTOMY HAD TO BE PERFORMED. DEBRIS WAS FOUND IN THE DISC SPACE. PROCEDURE INVOLVED WAS C5-7 CORPECTOMY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16076171 ↗
• InjurySep 12, 2022Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA THE MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING USE. IT WAS REPORTED THAT THERE WAS CAGE SUBSIDENCE AND MIGRATION. THE PRODUCT WAS EXPLANTED AND THERE WAS A REVISION FUSION SURGERY. NO OTHER PATIENT SYMPTOM / COMPLICATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15401986 ↗
• InjurySep 12, 2022Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA THE MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING USE. IT WAS REPORTED THAT THE C6 IMPLANT SETTLED WITH RECURRENT SYMPTOMS. THE PRODUCT WAS EXPLANTED USING DISTRACTION AND OSTEOTOME AND REPLACED WITH A MEDTRONIC PRODUCT. NO OTHER PATIENT SYMPTOM / COMPLICATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15401980 ↗
• InjuryDec 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE WAS NO PRODUCT MALFUNCTION.

  Patient problems: Unspecified Infection

  MAUDE report 11034487 ↗
• InjuryMar 30, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGERY IN WHICH ARTIFICIAL DISCS WERE IMPLANTED. FROM (B)(6) 2018, POST-OP, THE PATIENT STARTED HAVING SEVERE PAIN. HENCE, ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION SURGERY, IN WHICH THE IMPLANT WAS EXPLANTED FROM C6-C7 LEVEL. THE IMPLANT FRACTURED DURING THE REMOVAL PROCESS. NO FRAGMENT OF THE FRACTURED IMPLANT REMAINED INSIDE THE PATIENT. ANTERIOR/POSTERIOR FUSION WAS ALSO PERFORMED AT C4-C7 LEVEL IN THIS REVISION SURGERY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED POST REVISION SURGERY.

  Patient problems: Pain

  MAUDE report 8467930 ↗
• InjuryMar 27, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PRE-OPERATIVE DIAGNOSIS- CERVICAL STENOSIS PROCEDURE- CERVICAL DISC REPLACEMENT LEVELS IMPLANTED- C4-5 IT WAS REPORTED THAT, POST-OP, THE DEVICE WAS DISLODGED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8454984 ↗
• InjuryDec 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROCEDURE USED IN INITIAL SURGERY: ANTERIOR CERVICAL DISC ARTHROPLASTY (ACDA) REMOVAL C5/6 PREOPERATIVE DIAGNOSIS FOR REVISION: END STAGE SPONDYLOSIS WITH FORAMINAL STENOSIS PROCEDURE USED IN REVISION: ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) C3-C7 IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ACDA AT C5-6. POST-OP, PATIENT SUFFERED WITH END STAGE SPONDYLOSIS WITH FORAMINAL STENOSIS. AS A RESULT, PATIENT UNDERWENT AN ACDF WITH EXTENSION FROM C3-7. REVISION SURGERY HAD NO ISSUES AND WENT AS PLANNED.

  Patient problems: Spinal Column Injury; Stenosis

  MAUDE report 8132006 ↗
• InjuryOct 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: DEGENERATIVE DISK DISEASE IT WAS REPORTED THAT THE PATIENT UNDERWENT CERVICAL DISK ARTHROPLASTY AT C5-C6. ON AN UNKNOWN DATE, POST-OP, THE PATIENT HAD ARM AND NECK PAIN. ON (B)(6) 2017, ANTERIOR CERVICAL DISCECTOMY AND FUSION WAS PERFORMED TO REMOVE THE DEVICE. NO PRODUCT PROBLEM WAS REPORTED FOR THE IMPLANT.

  Patient problems: Neck Pain; Pain

  MAUDE report 6939586 ↗

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