Shoreline RT 85-6707Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889981164225), received between Aug 25, 2023 and Aug 25, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2023Migration or Expulsion of Device; Premature Separation; Migration or Expulsion of Device; Premature Separation

  THIS EVENT WAS INITIALLY REPORTED ON (B)(6). THIS REPORT IS BEING SUBMITTED TO PROVIDE THE INFORMATION OF THE 85-6707-SP INTERBODY, 20X15X7MM, 7 DEGREE, RT INVOLVED IN THE EVENT. SEASPINE WAS MADE AWARE ON (B)(6) 2023 THAT A PATIENT UNDERWENT SPINAL SURGERY CONSISTING OF SEASPINE' S SHORELINE SYSTEM. THE INDEX SURGERY TOOK PLACE ON (B)(6) 2022. THE X-RAY PROVIDED APPEARS TO SHOW THAT A SCREW LOOSENED POST-OPERATIVELY. ON (B)(6) 2023 THE REPORTER NOTED THAT AT THE 3-MONTH CHECKUP, THE SCREW HAD STARTED TO BACK OUT ALREADY AS OBSERVED ON A LATERAL X-RAY. AT A SUBSEQUENT CHECKUP ABOUT A MONTH AGO THE SURGEON OBSERVED THAT THE SCREW HAD BECOME COMPLETELY DISASSOCIATED WITH THE REST OF THE CONSTRUCT. THE REPORTER ADDED THAT THE CONSTRUCT SPAN FROM C5-C7. THE C5 AND C6 VERTEBRAL BODIES BOTH APPEAR TO HAVE SOME COLLAPSE TO THEM. THEY APPEAR TO BE MUCH SHORTER IN HEIGHT THAN THE ADJACENT LEVELS, MAKING THEM WONDER ABOUT BONE QUALITY. ALSO, DURING THE PROCEDURE THE RESIDENT TOOK A TRAJECTORY INTO C6 THAT DR. LENNARSON DIDN'T LIKE SO HE REVISED A COUPLE OF SCREWS DURING THE INDEX PROCEDURE. A REVISION SURGERY THEN TOOK PLACE ON (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17623449 ↗