Shoreline ACS 85-2006Recalls & reported problems
Seaspine Orthopedics Corporation · 6-7mm, No Profile 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10889981125042), received between Jun 9, 2025 and Mar 2, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Migration” (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.
Reports received per month
Most reported problems
Device problems
- Migration1
- Premature Separation1
- Separation Problem1
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 2, 2026Separation Problem
ORTHOFIX WAS MADE AWARE ON 03 FEB 2026 THAT A WAVEFORM C NO-PROFILE INTERBODY DEVICE LOCKING COVER WAS OBSERVED TO HAVE LOOSENED/BACKED OUT APPROXIMATELY SIX (6) WEEKS POSTOPERATIVELY. THE INDEX SURGERY OCCURRED ON (B)(6) 2025. THE SURGEON REPORTED THAT INTRAOPERATIVE FLUOROSCOPIC IMAGING (C-ARM) CONFIRMED THE LOCKING COVER WAS FLUSH AND FULLY SEATED AT THE TIME OF IMPLANTATION. AT APPROXIMATELY SIX WEEKS POSTOPERATIVELY, FOLLOW-UP IMAGING DEMONSTRATED THAT THE LOCKING COVER HAD MIGRATED/BACKED OUT FROM ITS ORIGINAL SEATED POSITION.
Patient problems: Insufficient Information
MAUDE report 24488463 ↗MalfunctionJul 15, 2025Migration; Migration
A PATIENT UNDERWENT ANTERIOR CERVICAL DISCECTOMY FUSION (ACDF) SPINE SURGERY ON (B)(6) 2025 UTILIZING SEASPINE/ORTHOFIX'S WAVEFORM C AND SHORELINE ACS SYSTEMS. ON (B)(6) 2025, SEASPINE/ORTHOFIX WAS NOTIFIED THAT THE SHORELINE ACS NO-PROFILE LOCKING COVER HAD PREMATURELY DISENGAGED FROM THE WAVEFORM C NO-PROFILE INTERBODY CONSTRUCT.
Patient problems: Insufficient Information
MAUDE report 22507315 ↗MalfunctionJun 9, 2025Premature Separation; Premature Separation
A PATIENT UNDERWENT ANTERIOR CERVICAL DISCECTOMY FUSION (ACDF) SPINAL SURGERY ON (B)(6) 2025. ON (B)(6) 2025, IT WAS OBSERVED DURING ROUTINE POSTOPERATIVE FOLLOW UP THAT THE NO PROFILE LOCKING COVER SEPARATED FROM THE NO PROFILE SPACER.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22168864 ↗
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