Shoreline ACS 85-1407-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889981124765), received between Aug 24, 2021 and May 5, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Migration” (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 18, 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.

• MalfunctionMay 5, 2022Migration; Migration

  PHYSICIAN HAD FOLLOW UP VISIT WITH PATIENT (B)(6) 2022, TO REVIEW MIGRATION OF REEF TA CAGE. CAGE WAS INSERTED FROM LEFT SIDED APPROACH, BUT HAS ROTATED 90 DEGREES AND APPEARS TO BE PROTRUDING 2MM BEYOND THE BORDER OF THE POSTERIOR DISC SPACE. PHYSICIAN ORDERED A CT SCAN FOR THE PATIENT. THERE IS NO EVIDENCE OF SCREW LOOSENING. EXPECTS PATIENT WILL NEED REVISION, BUT WILL KNOW MORE ONCE CT IMAGES ARE AVAILABLE. AT THE TIME OF THIS REPORT, NO CT SCANS HAVE BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14291757 ↗
• MalfunctionAug 24, 2021Migration; Migration

  UNKNOWN INDEX SURGERY WAS PERFORMED ON AN UNKNOWN DATE. NO ANTERIOR FIXATION WAS USED. AFTER THE SURGERY THE PATIENT EXPERIENCED PAIN IN THE RIGHT HAND. THE INTERBODY HAD MIGRATED ANTERIOR TO THE INTERVERTEBRAL SPACE AND HAD TO BE REPLACED. AN ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 WITH ANTERIOR FIXATION.

  Patient problems: Pain

  MAUDE report 12363393 ↗