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Shoreline ACS 85-2108Recalls & reported problems

Seaspine Orthopedics Corporation · 8mm, Locking Cover · Class 2 · Implant

All models of Shoreline ACS (16)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889981125097), received between Dec 1, 2022 and Dec 1, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Separation Failure” (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

Device problems

  • Separation Failure1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • InjuryDec 1, 2022Separation Failure; Separation Failure

    A PATIENT UNDERWENT CERVICAL SPINAL SURGERY ON (B)(6) 2022, WHICH CONSISTED OF SEASPINE'S WAVEFORM C AND SHORELINE INTERBODIES. SEASPINE WAS MADE AWARE ON (B)(6) 2022 OF A POSTOPERATIVE IMPLANT FAILURE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15895783 ↗

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Sources and updates

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