PRESTIGE® Cervical Disc System 6961660Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994129222), received between Dec 28, 2017 and Dec 28, 2017 — classified as 1 injury.

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.

• InjuryDec 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNSPECIFIED SPINAL SURGERY AT C5-C6. POST-OP, THE PATIENT HAD INFLAMMATION AND JOINT ISSUES IN THE AREA WHERE DISC WAS IMPLANTED. PATIENT UNDERWENT MRI, X-RAYS AND ALLERGY TESTING. NO REVISION SURGERY WAS PERFORMED.

  Patient problems: Inflammation

  MAUDE report 7153721 ↗

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-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
• 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-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-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-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