PCM 7680265Recalls & reported problems
Nuvasive, Inc. · Artificial Vertebral Disc, 6.5mm Small · Class 3 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517081124), received between Oct 26, 2015 and Nov 22, 2016 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).
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
Device problems
- Loose or Intermittent Connection1
- Migration or Expulsion of Device1
Patient problems
- Failure of Implant2
- Fall1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 22, 2016Migration or Expulsion of Device; Migration or Expulsion of Device
ON (B)(6) 2016, A (B)(6)FEMALE UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND IMPLANTATION OF A PROSTHETIC DEVICE. AROUND 3 MONTHS POST-OPERATIVELY, IT WAS REPORTED THE PATIENT FELL AND THE CAUDAL PORTION OF THE DEVICE MIGRATED ANTERIORLY. A REVISION SURGERY WAS PERFORMED (B)(6) 2016. THE DEVICE WAS EXPLANTED AND THE PATIENT RECEIVED AN ACDF.
Patient problems: Failure of Implant; Fall
MAUDE report 6121939 ↗MalfunctionOct 26, 2015Loose or Intermittent Connection
ON (B)(6), 2013, A PATIENT UNDERWENT A SINGLE LEVEL CERVICAL ARTHROPLASTY AT C5-6. APPROXIMATELY 30 MONTHS POSTOPERATIVE, THE PATIENT REPORTED NEW SYMPTOMS OF SIGNIFICANT NECK PAIN, BILATERAL ARM PAIN, HAND NUMBNESS, SHOOTING ELECTRICAL TYPE SENSATION DOWN HIS ARMS AND BILATERAL ARM WEAKNESS. HE STATES THIS STARTED AFTER HE JAMMED HIS HEAD INTO A VEHICLE DOOR WHEN HE WAS REACHING INTO HIS VEHICLE. HE REPORTS HE HAS PAIN ALL THE WAY INTO HIS ARMS AND INTO THE SECOND, THIRD, AND FOURTH DIGITS. THE SURGEON REPORTED LOOSENING OF BOTH THE CRANIAL AND CAUDAL COMPONENT. THERE WAS ALSO SUBSIDENCE REPORTED FOR THE CAUDAL COMPONENT. A REVISION SURGERY OCCURRED ON (B)(6), 2015.
Patient problems: Failure of Implant
MAUDE report 5178292 ↗
Other Prosthesis, Intervertebral Disc devices
- Prodisc C SK PDSM5Centinel Spine, LLC · Prosthesis, Intervertebral Disc2 recalls4 reports
- Simplify® Cervical Artificial DiscNuvasive, Inc. · Prosthesis, Intervertebral Disc1 recall12 reports
- Prodisc C 09.820.055SCentinel Spine, LLC · Prosthesis, Intervertebral Disc1 recall9 reports
- Simplify® Cervical Artificial DiscNuvasive, Inc. · Prosthesis, Intervertebral Disc1 recall4 reports
- Prodisc C SK PDSXL5Centinel Spine, LLC · Prosthesis, Intervertebral Disc1 recall3 reports
- Simplify® Cervical Artificial DiscNuvasive, Inc. · Prosthesis, Intervertebral Disc1 recall3 reports
- Simplify® Cervical Artificial DiscNuvasive, Inc. · Prosthesis, Intervertebral Disc1 recall3 reports
- Simplify® Cervical Artificial DiscNuvasive, Inc. · Prosthesis, Intervertebral Disc1 recall3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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