PRESTIGE® Cervical Disc System 6961460Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00613994129215), received between Jun 9, 2017 and Jan 15, 2020 — classified as 6 injuries.

The most frequently reported specific device problem is “Malposition of Device” (2 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 15, 2020Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CERVICAL SURGERY TO REPAIR DISC BULGE IN HER NECK. POST-OP, THE PATIENT CLAIMED THAT ABOUT 4 YEARS AGO SHE HAD A FALL WITH A CONCUSSION- SHE HAD ALSO BEEN INVOLVED IN TWO PREVIOUS AUTO ACCIDENTS (REAR-ENDED). PATIENT IS EXPERIENCING FOLLOWING PROBLEMS FOR ABOUT 3 YEARS: HOARSENESS; PROBLEMS SWALLOWING; LACK OF MUSCLE STRENGTH IN THROAT; NECK SPASMS; PAIN IN SHOULDERS AND UPPER BACK; PAINFUL BREATHING; DIGESTIVE PROBLEMS. CT SCAN FINALLY SHOWED THE IMPLANTED HARDWARE (DISC) IN HER NECK HAD SHIFTED. SHE HAS OVER TIME DEVELOPED SCOLIOSIS, KYPHOSIS, AND DYSPHAGIA. ONE DOCTOR TOLD HER IT WAS INOPERABLE AND COULDN'T BE REPAIRED. SHE THEN GOT A SECOND OPINION AND WAS TOLD IT WAS OPERABLE AND HER VERTEBRAE NEEDED TO BE FUSED AT 2 LEVELS, BUT SHE IS HAVING TROUBLE GETTING SOMEONE TO DO THE SURGERY. SHE ALSO CLAIMS THAT DOCTOR INITIALLY SUGGESTED REMOVAL, BUT NOW HIS MIND WOULD CHANGED. SHE WAS SEARCHING FOR ANOTHER NEUROSURGEON TO GIVE HER AN OPINION.

  Patient problems: Dysphagia/ Odynophagia; Muscle Spasm(s); Pain

  MAUDE report 9590162 ↗
• InjuryJun 1, 2018Break; Migration or Expulsion of Device; Break; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT UNSPECIFIED SURGERY. POST-OP, PATIENT HAD PAIN IN HIS NECK AND COULDN'T MOVE HIS HEAD. X-RAY IMAGE REVEALED THAT THE SCREW WAS BROKEN AND PART OF THE SCREW WAS STRUCK IN THE BONE. A REVISION WAS PERFORMED AS THE RESULT OF THE EVENT. THE DEVICE SLID OUT AND WAS NOT HELD IN PROPERLY.

  Patient problems: Neck Pain

  MAUDE report 7559533 ↗
• InjuryMay 16, 2018Component Falling; Component Falling

  LEVELS IMPLANTED: C5-C6 PRIOR SURGERIES: DISCECTOMY OF L5 S1 IN 2005, A FUSION OF C2-C3 DONE IN 2006. IT WAS REPORTED BY PATIENT THAT ON AN UNKNOWN DATE, POST-OP, FROM 2009 THE PATIENT IS SUFFERING WITH NECK PROBLEMS ALONG WITH EARLIER THE LOWER BACK PAIN. ON (B)(6) 2018, THE PATIENT WAS HAVING PROBLEM SWALLOWING AND EATING SO HIS WIFE TOOK HIM TO THE HOSPITAL. THE ENT THERE TOLD HIM THAT THEY MIGHT HAVE TO OPERATE ON HIS NECK BECAUSE SHE THOUGHT THE DISC WAS FALLING APART AND CAUSING THE PAIN AND THE PROBLEMS SWALLOWING. AS REPORTED, THE PATIENT NECK WAS HUGE AND EXTREMELY RED AND HE WAS HOT TO THE TOUCH. THE ENT RECOMMENDED PATIENT TO GO HOME AND COME BACK ON (B)(6) WHICH THE PATIENT DID. SHE DREW BLOOD AND WAS WORKING ON THE TREATMENT PLAN WHILE THE PATIENT WAS HEADING HOME. PATIENT RECEIVED A CALL FROM ENT DOCTOR TELLING THAT PATIENT HAD TO GET TO THE HOSPITAL AS QUICKLY AS POSSIBLE. THE ENT CONFIRMED THAT SHE HAD OPENED THE PATIENT AND FOUND AN INFECTION IN THE AREA OF THE ARTIFICIAL DISC. SHE HAD PULLED OUT APPROXIMATELY 8 CC OF INFECTED PUS AROUND THE DISC AND NOTED THAT SHE FOUND SOMETHING SIMILAR TO COFFEE GROUNDS IN THIS AREA TOO. THE PATIENT RELEASED FROM THE HOSPITAL ON

  Patient problems: Neck Pain; Neck Stiffness; Unspecified Infection

  MAUDE report 7517462 ↗
• InjuryAug 8, 2017Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT ON (B)(6) 2016 (YEAR VALID), PATIENT UNDERWENT SURGERY AT LEVEL C6-7 DUE TO PRE-OP DIAGNOSIS: STENOSIS AT C6-7 ALONG WITH BONE SPURS. TWO STAINLESS STEEL METAL PLATES WERE INSTALLED WHERE THE BOTTOM PLATE WAS PARALLEL WITH SHOULDER BUT THE TOP PLATE IS AT AN ANGLE OF 15 DEGREES. DUE TO THE MALPOSITION OF CERVICAL DISC DEVICE, PATIENT IS UNABLE TO GO MORE THAN 4 "PT' SESSIONS DUE TO THE INCREASE IN PAIN. ALLEGEDLY, PATIENT CONTINUES TO EXPERIENCE PAIN IN THE NECK AREA GOING DOWN THE RIGHT SHOULDER TO ELBOW.

  Patient problems: Neck Pain; Pain

  MAUDE report 6773005 ↗
• InjuryAug 4, 2017Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT PRE OPERATIVELY PATIENT WAS HAVING PAIN WHICH IS GOING DOWN THE LEFT SHOULDER, ARM, HAND. THIS OCCURRED PERIODICALLY WITHOUT MUCH WARNING. THE MRI DETECTED STENOSIS AT C6-7 ALONG WITH BOND SPURS. THE PAIN CAME AT A TIME THAT RENDERED PATIENT UNABLE TO DRIVE, WHICH CAUSED AN AUTO ACCIDENT. ALLEGEDLY, THE TWO STAINLESS STEEL METAL PLATES WERE INSTALLED WHERE THE BOTTOM PLATE WAS PARALLEL WITH THE SHOULDER, BUT THE UPPER PLATE WAS AT AN ANGLE OF 15 DEGREES. POST OPERATIVELY, WITH THE MALPOSITION OF THE CERVICAL DISC DEVICE, PATIENT WAS UNABLE TO GO MORE THAN 4 PT SESSIONS DUE TO THE INCREASE IN PAIN. HE PLANNED TO PROVIDE PERMISSION TO REVIEW HIS X-RAY, WHICH CLEARLY SHOWS THE MALPOSITION. IT LOOKS LIKE ONE HOLE WAS DRILLED IN THE WRONG POSITION. PATIENT WAS EXPERIENCING PAIN IN THE NECK AREA GOING DOWN THE RIGHT SHOULDER TO HIS ELBOW.

  Patient problems: Neck Pain

  MAUDE report 6766240 ↗
• InjuryJun 9, 2017Metal Shedding Debris; Metal Shedding Debris

  IT WAS REPORTED THAT ON (B)(6) 2008 (YEAR VALID), PATIENT UNDERWENT ANTERIOR CERVICAL DISC ARTHROPLASTY AT LEVELS C5-6. ON (B)(6) 2017, PATIENT PRESENTED WITH PRE-OP DIAGNOSIS AS: FAILED ARTHROPLASTY C5-6 AND ADJACENT DEGENERATIVE DISC DISEASE C6-7. FOR WHICH PATIENT UNDERWENT REVISION SURGERY. SURGEON NOTICED WEAR DEBRIS AROUND DEVICE UPON EXPLANTING. THERE WAS WEAR DEBRIS (BLACK TISSUE) AT THE SITE. THE SURGEON LABELED IT AS FAILED ARTHROPLASTY BECAUSE THERE WAS NO MOVEMENT IN THAT SEGMENT ON X-RAY AND BONE CAN BE SEEN BEHIND THE ARTIFICIAL CERVICAL DISC IN THE DISC SPACE. PER REPS'S PERSONAL OBSERVATION, THE DISC WAS NOT PROPERLY SIZED WHEN IMPLANTED. PER IMAGE (NOT AVAILABLE FOR RETURN), REP FOUND THAT THE BALL AND TROUGH WAS IN THE MIDDLE OF THE DISC SPACE WITH 3-4 MM OF ROOM BEHIND IT, NOT IN THE POSTERIOR PART OF SPACE AS IT SHOULD BE AND THIS MIGHT HAVE CONTRIBUTED TO THE AUTO FUSION AND HENCE THE DISC NOT WORKING AS IT SHOULD.

  Patient problems: No Code Available

  MAUDE report 6629095 ↗

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-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-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-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-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