PRESTIGE LP™ 6972450Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00613994493712), received between Oct 17, 2017 and Sep 18, 2025 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Biocompatibility” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2025Biocompatibility; Biocompatibility

  INFORMATION WAS RECEIVED FROM A CONSUMER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING POST-OP OF THE REPORTED PRODUCTS. IT WAS REPORTED THAT, PATIENT EXPERIENCED RASH PAIN ACROSS CHEST, PAIN, SWELLING, DIAGNOSED CRPS TYPE 1, OSTEOPHYTES IN NECK, BONE ABOVE AND BELOW IMPLANTS IS DETERIORATING, BLURRY VISION, HEADACHES, EXTREME REACTION TO NICKEL AND COBALT. CERVICAL DISCS WERE IMPLANTED AT LEVELS C5-C6 AND C6-C7. THE IMPLANTS ARE BEING REMOVED THIS MONTH DUE TO TITANIUM ALLERGY. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Blurred Vision; Complex regional pain syndrome; Exostosis (bone); Headache; Hypersensitivity/Allergic reaction; Osteopenia/ Osteoporosis; Pain; Rash; Swelling/ Edema

  MAUDE report 23082371 ↗
• InjurySep 18, 2025Biocompatibility; Biocompatibility

  INFORMATION WAS RECEIVED FROM A CONSUMER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING POST-OP OF THE REPORTED PRODUCTS. IT WAS REPORTED THAT, PATIENT EXPERIENCED RASH PAIN ACROSS CHEST, PAIN, SWELLING, DIAGNOSED CRPS TYPE 1, OSTEOPHYTES IN NECK, BONE ABOVE AND BELOW IMPLANTS IS DETERIORATING, BLURRY VISION, HEADACHES, EXTREME REACTION TO NICKEL AND COBALT. CERVICAL DISCS WERE IMPLANTED AT LEVELS C5-C6 AND C6-C7. THE IMPLANTS ARE BEING REMOVED THIS MONTH DUE TO TITANIUM ALLERGY. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Blurred Vision; Complex regional pain syndrome; Exostosis (bone); Headache; Hypersensitivity/Allergic reaction; Osteopenia/ Osteoporosis; Pain; Rash; Swelling/ Edema

  MAUDE report 23082273 ↗
• InjuryJul 12, 2021Migration; Migration

  INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE REGRADING AN EVENT WHICH OCCURRED AFTER A C4/5, C5/6 ACDF PROCEDURE. THE DEVICE WAS EXPLANTED SINCE IT WAS SHIFTING FORWARD AND WAS CAUSING SWALLOWING ISSUES TO THE PATIENT. THE REVISION SURGERY WAS PERFORMED AND THE CAGES WERE EXPLANTED.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 12148712 ↗
• InjuryJul 12, 2021Migration; Migration

  INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE REGRADING AN EVENT WHICH OCCURRED AFTER A C4/5, C5/6 ACDF PROCEDURE. THE DEVICE WAS EXPLANTED SINCE IT WAS SHIFTING FORWARD AND WAS CAUSING SWALLOWING ISSUES TO THE PATIENT. THE REVISION SURGERY WAS PERFORMED AND THE CAGES WERE EXPLANTED.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 12148708 ↗
• InjuryJan 11, 2021Difficult to Remove; Use of Device Problem; Material Protrusion/Extrusion; Difficult to Remove; Use of Device Problem; Material Protrusion/Extrusion

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH PRESTIGE LP DEVICE SPITTING AN TERIORLY INVOLVED IN ANTERIOR CERVICAL DISCECTOMY. LEVELS IMPLANTED- 5/6. IT WAS REPORTED THAT POST-OP, IMPLANT USED IN THE INITIAL SURGERY WAS IMPROPERLY SIZED. THE IMPLANT USED WAS 14MM IN DEPTH AND SHOULD HAVE BEEN 16MM. IN THE INITIAL SURGERY TWO LP DEVICES WERE IMPLANTED. THE LP DEVICE IMPLANTED AT LEVEL 6/7 WAS FINE AND DID NOT REPORT ANY ISSUE. THE SIZE OF THE DEVICE IMPLANTED AT LEVEL 6/7 WAS 5MM X 16MM. THE EXPLANTED DEVICE THAT IS OF 14MM REPORTED FOR PROTRUDING. THE FORCES CREATED POSTERIORLY IN THE DISC SPACE DURING EXTENSION PUSHED THE IMPLANT ANTERIORLY SLIGHTLY. THE SURGEON STATED THAT THEY BELIEVED THE DEVICE WAS NOT THE SOLE REASON FOR THE RE-OPERATION, AND WHEN TRIED TO REMOVE THE DEVICE IT WOULD NOT COME EASILY AND REQUIRED A SIGNIFICANT AMOUNT OF FORCE TO REMOVE. PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. RECURRING RADICULOPATHY DOWN RIGHT ARM TO ELBOW WAS REPORTED. ADDITIONAL TREATMENT OR SURGERY WAS PERFORMED, PREVIOUSLY A TWO LEVEL ARTHROPLASTY WAS DONE. REMOVED THE LP AT 5/6 AND PLACED AN ALLOGRAF

  Patient problems: Neuropathy

  MAUDE report 11146793 ↗
• MalfunctionMar 28, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH DISC HERNIATION AT C5-C6; AND UNDERWENT ANTERIOR CERVICAL DISCECTOMY WITH CERVICAL ARTHROPLASTY AND IMPLANTATION OF MOTION PRESERVING DEVICE AT C5-C6. IMPLANTATION WAS UNEVENTFUL AND NO KNOWN COMPLICATIONS WERE NOTED IMMEDIATELY AFTER THE SURGERY. ON (B)(6) 2020, POST-OP AND AFTER THE PATIENT'S STANDARD FOLLOW-UP APPOINTMENT, THE SURGEON INFORMED THAT THE PATIENT'S RADIOGRAPHS SHOWED THE IMPLANT TO HAVE EXPULSED ANTERIORLY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9894002 ↗
• InjuryJul 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CERVICAL SURGERY AT C5/C6 DUE TO SOME UNKNOWN REASONS WHERE AN ARTIFICIAL DISC HAS BEEN IMPLANTED. POST-OP, APPROXIMATELY 6 WEEKS AGO PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) WITH COMPLAINTS OF PAIN IN BOTH UPPER EXTREMITIES DUE TO HER CHILD JUMPED ON HER NECK. ALSO, THE PATIENT HAD ALLERGIC REACTIONS DUE TO METAL AND POSSIBLE TISSUE SCAR. AS A RESULT OF THIS THE PATIENT UNDERWENT REVISION SURGERY DUE TO POSSIBLE METAL ALLERGY REACTION AND INCREASED SCAR TISSUE, WHEREIN THE IMPLANTED DISC WAS COMPLETELY EXPLANTED.

  Patient problems: Neck Pain; Reaction

  MAUDE report 8829857 ↗
• InjuryOct 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT ARTHROPLASTY AT C5/C6 DUE TO CERVICAL HERNIATED DISC. REPORTEDLY, POST-OP, THE PATIENT SUFFERED WITH DEGENERATIVE DISC DISEASE DUE TO FAILED IMPLANT AND UNDERWENT REVISION SURGERY FOR REMOVAL. THE IMPLANT WAS REMOVED WITH A ¼ OSTEOTOME AND A CLAMP. NO PATIENT COMPLICATIONS WERE REPORTED AFTER THE REVISION SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 6953991 ↗

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