PRESTIGE LP™ 6972650Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00613994493675), received between Mar 30, 2019 and Jan 24, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 24, 2024Mechanical Problem; Migration; Mechanical Problem; Migration

  INFORMATION WAS RECEIVED FROM A PATIENT VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING A PRESTIGE LP DISC THAT WAS PUT IN HER CERVICAL SPINE FOR OSTEOPOROSIS. IT WAS REPORTED THAT THE PATIENT HAD X-RAY ON (B)(6) 2023, DISC SPACE COLLAPSED AND IMPLANT MOVED INTO THE VERTEBRAL BODY. PATIENT IS EXPERIENCING PAIN AND NUMBNESS IN HER HAND AND ARM. PATIENT HAD OSTEOPOROSIS AT THE TIME THE DISC PUT IN AND IT FAILED NOT EVEN 2 YEARS LATER.  NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Numbness; Pain

  MAUDE report 18569434 ↗
• InjuryMay 17, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING POST - OPERATIVELY FOR AN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT, THE IMPLANTED CAGE WAS DISLODGED BECAUSE, THE PATIENT VOMITED VIOLENTLY. PATIENT GOT SICK UNRELATED TO THE IMPLANT. THE REPORTED PRODUCT WAS EXPLANTED. PATIENT HAD A SYMPTOM OF TROUBLE IN SWALLOWING. REVISION WAS PERFORMED AND EXPLANTED THE CAGE. HCP MENTIONED THAT, THE CAGE WAS DISLODGED DUE TO VIOLENT VOMITING. TO OVERCOME THE TROUBLE IN SWALLOWING, PATIENT UNDERGONE REVISION SURGERY TO EXPLANT PRESTIGE AND DID TRADITIONAL ACDF WITH ATLANTIS VISION ELITE. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 11830714 ↗
• InjuryFeb 17, 2021Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING PATIENT WITH INTERMITTENT BURNING IN NECK, BILATERAL UPPER EXTREMITY NUMBNESS, VENTRAL PROTRUSION SUGGESTED FOR C4-7 ANTERIOR CERVICAL DISECTOMY AND FUSION. THIS EVENT WAS REVISION SURGERY. EVENT OCCURRED INTRA-OP. IT WAS REPORTED THAT PROCEDURE WAS TO REMOVE A PRESTIGE LP IMPLANT FROM THE LEVEL OF C5-6. DEVICE WAS IMPLANTED ON (B)(6) 2019 AND DATE OF EXPLANT WAS (B)(6) 2021. NO PATIENT SYMPTOMS REPORTED. DEVICE IS BEING RETURNED. NO FURTHER COMPLICATIONS REPORTED. PATIENTS SYMPTOMS CONTINUED AND WERE NOT FIXED BY THE PRESTIGE IMPLANT. PATIENT ALSO COMPLAINED OF A ¿GLITCH¿ WITH THE PRESTIGE LP IMPLANT.

  Patient problems: Burning Sensation; Numbness

  MAUDE report 11336687 ↗
• InjuryJun 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE SALES REPRESENTATIVE GUESS, THE CAUSE WAS CONSIDERED THAT THE CENTER OF ROTATION OF DISC WAS DESIGNED TO BE LOCATED SLIGHTLY POSTERIOR TO THE CENTER OF THE LOWER IMPLANT (A LITTLE BEHIND THE MIDDLE OF THE LOWER VERTEBRAL BODY). (THE SALES REP DID NOT THINK THAT IT WAS A PREOPERATIVE FACTOR.) IT WAS THOUGHT THAT THE SCOLIOSIS POSITION WILL BE BETTER IF THE COR IS LOCATED SLIGHTLY ANTERIOR. HOWEVER, ON THE OTHER HAND, BECAUSE COR HAS BEEN IN ITS CURRENT POSITION, IT WAS THOUGHT THAT THE IMPLANT ITSELF WAS FIRMLY FIXED WITH THE LOWER VERTEBRAL BODY AND WAS STABLE. SINCE IT WAS TWO PIECES OF IMPLANT, IT WAS THOUGHT THAT THE LOCATION OF COR WAS VERY IMPORTANT. THE PATIENT ALSO WENT FOR FURTHER DIAGNOSIS ON (B)(6) 2020. AS FOR THE CLINICAL COURSE, IT WAS SAID THAT THE PATIENT FELT THAT THE NECK WAS A LITTLE HEAVY SOMETIMES, PREOPERATIVE PAIN AND NUMBNESS HAD IMPROVED.

  Patient problems: Loss of Range of Motion

  MAUDE report 10136731 ↗
• 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 C5-C6 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 8467928 ↗

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