PCM 7680365Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887517081155), received between Dec 20, 2015 and May 4, 2017 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (3 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.

• MalfunctionMay 4, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IN 2013 A (B)(6) YEAR OLD, (B)(6) POUND FEMALE RECEIVED A PCM IMPLANT AT THE C5-C6 LEVEL. IN 2015 THE PATIENT BEGAN TO EXPERIENCE PAIN IN HER LEFT ARM. RADIOGRAPHIC EVALUATION CONFIRMED ANTERIOR MIGRATION OF THE INFERIOR PROSTHESIS PLATE. REVISION SURGERY OCCURRED ON 4/20/2017 AND THE PROSTHESIS WAS EXPLANTED AND AN ACDF PROCEDURE WAS PERFORMED. THE PATIENT HAS BEEN CONFIRMED TO BE DOING WELL POST-REVISION.

  Patient problems: Failure of Implant; Pain

  MAUDE report 6546457 ↗
• MalfunctionMar 28, 2016Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2015, A (B)(6) YEAR OLD MALE UNDERWENT ANTERIOR CERVICAL DISCECTOMY WITH ANTROPLASTY. DURING A POSTOPERATIVE VISIT, THE PATIENT REPORTED SUDDEN ONSET OF NECK PAIN AND HEADACHE. A REVISION SURGERY OCCURRED ON (B)(6) 2016 TO REMOVE THE DEVICE. IT WAS NOTED THE CAUDAL PORTION OF THE DEVICE HAD MIGRATED ANTERIOR 7MM AND THE CRANIAL PORTION WAS STILL IN THE ORIGINAL POSITION.

  Patient problems: Failure of Implant; Headache; Neck Pain

  MAUDE report 5530693 ↗
• MalfunctionDec 20, 2015Migration or Expulsion of Device

  A (B)(6) MALE PATIENT UNDERWENT A TWO-LEVEL TOTAL DISC REPLACEMENT AT C5-6 AND C6-7 ON (B)(6) 2015. POSTOPERATIVE IMAGING CONFIRMED THE DISC REPLACEMENT TO BE WELL POSITIONED ON INITIAL POSTOPERATIVE X-RAYS. AROUND 11 MONTHS POSTOPERATIVE, IT WAS NOTED THAT THE INFERIOR ENDPLATE OF THE DEVICE AT C5-6 HAD MIGRATED.

  Patient problems: Failure of Implant

  MAUDE report 5312927 ↗