PRESTIGE® Cervical Disc System 6961470Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00721902723254), received between Mar 25, 2019 and Mar 25, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

6 other recalls cover devices cleared under the same FDA submission (P060018); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2019Break; Break

  PRE-OPERATIVE DIAGNOSIS: SUPERFICIAL SIDEROSIS LEVEL IMPLANTED: C3-C4 IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND ARTHROPLASTY SURGERY. POST-OP, ONE SCREW OF THE DISC BROKE AND DISTAL TIP WAS NOT RETRIEVED. REMOVAL OF DEVICE AND FUSION OF INDEX LEVEL WAS A REVISION SURGERY THAT WAS PERFORMED. SURROUNDING PRODUCT TISSUE PRIOR AND AFTER TO EXPLANATION WAS BLACKENED. BROKEN FRAGMENT REMAINS IN THE PATIENT. GENERAL INCREASING WEAKNESS AND IMAGING CONFIRMED DIAGNOSIS OF SIDEROSIS AS A PATIENT COMPLICATION. PATIENT SYMPTOMS MAY BE CAUSED BY LEAKAGE OF CHRONIC CSF LEAK DURING THE PROCEDURE.

  Patient problems: Cerebrospinal Fluid Leakage; Device Embedded In Tissue or Plaque; Host-Tissue Reaction; Weakness

  MAUDE report 8450276 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P060018. One submission often covers many models, so check the product and lot details in each record.

• Z-0138-2008 · Sep 4, 2007 · Terminated
  Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972226, SIZE 6 X 12, MATL: Stainless Steel/Titanium, Rx only, Manufactured at: Bartlett, Te
• Z-0140-2008 · Sep 4, 2007 · Terminated
  Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972266, SIZE 6 X 16, MATL: Stainless Steel/Titanium, Rx only, Manufactured at: Bartlett, Te
• Z-0142-2008 · Sep 4, 2007 · Terminated
  Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog: 6972267, SIZE 7 X 16, MATL: Stainless Steel/Titanium, Rx only, Manufactured at: Bartlett, Ten
• Z-0143-2008 · Sep 4, 2007 · Terminated
  Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972287, SIZE 7 X 18, MATL: Stainless Steel/Titanium, Rx only, Manufactured at: Bartlett, T
• Z-0139-2008 · Sep 4, 2007 · Terminated
  Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972246, SIZE 6 X 14, MATL: Stainless Steel/Titanium, Rx only, Manufactured at: Bartlett, T
• Z-0141-2008 · Sep 4, 2007 · Terminated
  Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972247, SIZE 7 X 14, MATL: Stainless Steel/Titanium, Rx only, Manufactured at: Bartlett, T