Shoreline ACS 85-0206-SRecalls & reported problems
Seaspine Orthopedics Corporation · No Profile Spacer, 16x14x6mm, 7 Degree, Sterile · Class 2
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 00889981124017), received between Aug 9, 2024 and Aug 9, 2024 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Neck Pain1
- Numbness1
- Unspecified Nervous System Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2023, A PATIENT UNDERWENT SPINAL SURGERY CONSISTING OF SEASPINE'S SHORELINE ANTERIOR CERVICAL INTERBODY SYSTEM, NOVABONE'S SYNTHETIC BIOGLASS BONE GRAFT, AND DYMICRON'S TRIADYME-C CERVICAL DISC. AFTER SIX MONTHS, THE PATIENT BEGAN EXPERIENCING RADICULAR PAIN, NUMBNESS, AND CERVICAL PAIN. ON (B)(6) 2024 THE PATIENT UNDERWENT A REVISION SURGERY AS THEY WERE "REFERRING DURAL COMPRESSION DUE TO A PSEUDO-TUMOR." ALL PREVIOUSLY IMPLANTED MATERIAL WAS REMOVED. NO FURTHER INFORMATION ON THE EVENT OR PATIENT CONDITION WAS PROVIDED.
Patient problems: Neck Pain; Numbness; Unspecified Nervous System Problem
MAUDE report 19950658 ↗
Other Intervertebral fusion device with integrated fixation, cervical devices
- NA 03.617.902Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical103 reports
- NA 03.617.900Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical77 reports
- Divergence® Anterior Cervical Fusion System G6626525Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, cervical75 reports
- Divergence® Anterior Cervical Fusion System G6626526Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, cervical49 reports
- NA 03.617.905Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical29 reports
- NA 03.617.904Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical27 reports
- Divergence® Anterior Cervical Fusion System G6626746Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, cervical21 reports
- NA 03.647.972Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical17 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page