PCM 7680465Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887517081186), received between Dec 14, 2015 and Sep 19, 2016 — classified as 3 malfunctions.

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

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2016Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2016, A PROSTHESIS DEVICE WAS IMPLANTED INTO A PATIENT AT LEVEL C5-6. APPROXIMATELY 4 MONTHS FOLLOWING SURGERY, A RADIOGRAPHIC IMAGE INDICATED THE INFERIOR ENDPLATE HAD MIGRATED ANTERIORLY. THE DEVICE WAS REMOVED (B)(6) 2016 AND AN ANTERIOR CERVICAL FUSION WAS PERFORMED.

  Patient problems: Failure of Implant

  MAUDE report 5961070 ↗
• MalfunctionDec 21, 2015Migration or Expulsion of Device

  A (B)(6) YEAR OLD MALE UNDERWENT A C6-7 DISCECTOMY AND BILATERAL FORAMINOTOMY, RECEIVING A CERVICAL DISC ARTHROPLASTY DEVICE. IT WAS NOTED 3 MONTHS POSTOPERATIVE THAT THE DEVICE MIGRATED APPROXIMATELY 3MM IN THE ANTERIOR DIRECTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5316193 ↗
• MalfunctionDec 14, 2015Adverse Event Without Identified Device or Use Problem

  IN (B)(6) 2014, PATIENT UNDERWENT A SINGLE LEVEL CERVICAL ARTHROPLASTY AT C5-6. ON (B)(6) 2015 PATIENT REPORTED NECK PAIN. REVISION SURGERY WAS PERFORMED ON (B)(6) 2015.

  Patient problems: Failure of Implant; Pain

  MAUDE report 5294368 ↗