Shoreline ACS 85-2107Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10889981125080), received between Aug 25, 2023 and Sep 21, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Accessory Incompatible” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Accessory Incompatible

  Patient problems: Insufficient Information

  MAUDE report 50846941 ↗
• InjurySep 9, 2026Fracture

  Orthofix was made aware on 12 AUG 2026 that a patient underwent spinal surgery consisting of the Shoreline ACS system. The index surgery occurred on (b)(6) 2026. It was reported that an 85-2107 7mm, Locking Cover fractured into the interbody intra-operatively and the threaded portion was left in the interbody. The fracture occurred when the surgeon tried to advance the 85-2107 7mm, Locking Cover using the Locking Handle. According to the reporter, the 85-2107 7mm, Locking Cover did not advance and was not seated properly. Since the interbody was already fixated at C6-7 with the screws, the surgeon elected to leave the construct in place and not remove the fractured threaded portion of the Locking Cover. No patient injuries or additional medical intervention were reported. Per the reporter, the patient is recovering well.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50693454 ↗
• InjuryMay 14, 2024Separation Failure; Separation Failure

  SEASPINE BECAME AWARE ON 25 APR 2024, THAT A REVISION SURGERY TOOK PLACE ON (B)(6) 2024, DUE TO LOOSENING OF A LOCKING COVER AND SCREW FOLLOWING THE INITIAL SURGERY ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19308682 ↗
• InjuryAug 25, 2023Migration or Expulsion of Device; Premature Separation; Migration or Expulsion of Device; Premature Separation

  THIS EVENT WAS INITIALLY REPORTED ON 3012120772-2023-00009. THIS REPORT IS BEING SUBMITTED TO PROVIDE THE INFORMATION OF THE 85-2107 7MM, LOCKING COVER INVOLVED IN THE EVENT. SEASPINE WAS MADE AWARE ON 03 APRIL 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 11 APRIL 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 17623442 ↗