Shoreline ACS 85-2008Recalls & reported problems
Seaspine Orthopedics Corporation · 8-12mm, 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889981125059), received between Jan 30, 2025 and Jan 30, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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
- Loosening of Implant Not Related to Bone-Ingrowth1
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.
MalfunctionJan 30, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
ON 09-JAN-2025, SURGEON REPORTS AN X-RAY SHOWED A SHORELINE ACS NO PROFILE LOCKING COVER BACKED OUT OF A WAVEFORM C NO PROFILE CAGE (BELIEVED TO BE AN 8MM CAGE AND 8-12MM NO PROFILE LOCKING COVER). THIS WAS OBSERVED AT THE PATIENT'S 3-MONTH FOLLOW-UP APPOINTMENT (EXACT DATE NOT PROVIDED). CUSTOMER STATES THERE WERE NO ABNORMALITIES TO SURGICAL TECHNIQUE OBSERVED DURING THE CASE. THE PATIENT DOES NOT HAVE ANY SYMPTOMS OR DIFFICULTY SWALLOWING. THE SURGEON DOES NOT PLAN TO PERFORM REVISION SURGERY AT THIS TIME. ALTHOUGH THREE FOLLOW-UP ATTEMPTS WERE PERFORMED, CUSTOMER WAS UNRESPONSIVE. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS EVENT. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21277648 ↗
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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.
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