PCM 7680372Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517081162), received between May 16, 2016 and Jun 19, 2018 — classified as 2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2018 PATIENT UNDERWENT A PROCEDURE WHERE A POROUS COATED MOTION (PCM) DEVICE WAS USED. A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2018 DUE TO A MIGRATION OF THE DEVICE. NO PATIENT INJURY HAS BEEN REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 7614527 ↗
• MalfunctionMay 16, 2016Migration or Expulsion of Device; Migration or Expulsion of Device

  INITIAL SURGERY WAS PERFORMED (B)(6) 2016, DURING WHICH A PROSTHETIC DEVICE WAS IMPLANTED AT THE C5-6 DISC SPACE. APPROXIMATELY 5 WEEKS FOLLOWING SURGERY, IT WAS NOTED THE PROSTHESIS HAD MIGRATED ANTERIORLY. THE AFFECTED LEVEL WAS REVISED ON (B)(6) 2016. PATIENT CONDITION AND STATUS OF HEALTH PRIOR TO EVENT IS UNKNOWN. PATIENT ACTIVITY LEVEL, BONE QUALITY, AND COMPLIANCE WITH POST-SURGICAL INSTRUCTIONS ARE UNKNOWN.

  Patient problems: No Information

  MAUDE report 5656018 ↗