Shoreline 86-0012Recalls & reported problems
Seaspine Orthopedics Corporation · Inserter, Straight · Class 2
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 10889981162696), received between Dec 16, 2021 and Dec 16, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Integrity Problem” (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
- Material Integrity Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 16, 2021Material Integrity Problem; Material Integrity Problem
ON (B)(6) 2021, SURGEON USED A SHORELINE INSERTER (86-0012) TO IMPLANT A WAVEFORM C IMPLANT. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE DISTAL TIP OF THE SHORELINE INSERTER HAD SNAPPED OFF AND THE FRAGMENT REMAINED IN THE INTERBODY. THE SURGERY WAS NOTED TO HAVE COMPLETED WITH NO COMPLICATIONS. IT IS UNKNOWN IF ALL FRAGMENTS WERE REMOVED AND ACCOUNTED FOR. UNKNOWN IF FRAGMENTS WERE REMOVED AND ACCOUNTED FOR.
Patient problems: Insufficient Information
MAUDE report 13015625 ↗
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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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