Shoreline ACS 85-3016Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10889981125172), received between Oct 6, 2023 and Apr 17, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2025Off-Label Use; Off-Label Use

  IT WAS REPORTED ON (B)(6) 2024 THAT THREE (3) SHORELINE 3.5MM VARIABLE ANGLE (VA), SELF-TAPPING, 16MM SCREWS WERE INADVERTENTLY IMPLANTED INTO AN ADMIRAL CERVICAL PLATE DURING A MULTI-LEVEL ACDF PROCEDURE (C3-C7). THE SHORELINE SCREWS WERE USED IN COMBINATION WITH FIVE (5) ADMIRAL 4.0MM SCREWS IN A 3-LEVEL ADMIRAL PLATE CONSTRUCT. ACCORDING TO THE DISTRIBUTOR PRESENT IN THE OPERATING ROOM, THE SHORELINE SCREWS WERE PLACED PROXIMALLY, APPEARED FULLY SEATED, AND ALL LOCKING COVERS WERE VISIBLY ENGAGED. THE SURGEON ELECTED TO RETAIN THE CONSTRUCT AFTER CONFIRMING INTRAOPERATIVE STABILITY AND EXPRESSED CONFIDENCE IN THE FIXATION. NO ADVERSE PATIENT OUTCOME HAS BEEN REPORTED TO DATE. THIS EVENT INVOLVED THE OFF-LABEL USE OF SHORELINE SCREWS IN AN ADMIRAL PLATE SYSTEM, A COMBINATION THAT HAS NOT BEEN VALIDATED OR TESTED FOR CROSS-COMPATIBILITY. THE DISCREPANCY WAS IDENTIFIED POSTOPERATIVELY DURING A FOLLOW-UP DISCUSSION WITH THE DISTRIBUTOR AND TERRITORY MANAGER. NO PATIENT INJURY, EXPLANTATION, OR ADDITIONAL INTERVENTION WAS REQUIRED. AT THE TIME OF INITIAL COMPLAINT REVIEW, THE EVENT WAS DEEMED NON-REPORTABLE DUE TO THE ABSENCE OF HARM AND THE MECHANICAL INTEGRITY OF THE CONSTRUCT. HOW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21859511 ↗
• MalfunctionOct 6, 2023Fracture; Fracture

  ON 15 SEP 2023 SEASPINE WAS MADE AWARE THAT A SHORELINE SYSTEM SCREW WAS FRACTURED AT THE 1-YEAR POST-OPERATIVE APPOINTMENT. ADDITIONAL INFORMATION WAS RECEIVED ON 26 SEP 2023 THAT SCREWS WERE FRACTURED ON THE BOTTOM LEVELS OF BOTH IMPLANTS. THE INDEX SURGERY OCCURRED ON (B)(6) 2022. NO FURTHER INFORMATION ON THE ORIGINAL PROCEDURE WAS PROVIDED. IT WAS NOTED THAT THE FIRST SCREW WAS FRACTURED ON (B)(6) 2023. NO REPORT HAD BEEN RECEIVED BY THE COMPANY AT THAT TIME. PATIENT CONDITION WAS NOT PROVIDED. A REVISION SURGERY OCCURRED ON (B)(6) 2023 CONSISTING OF A TWO-LEVEL CORPECTOMY USING ULRICH SOLIDITY AND SEASPINE ADMIRAL PLATE, C5-T1 PCF.

  Patient problems: Insufficient Information

  MAUDE report 17889684 ↗