Mariner MIS MM2-100050Recalls & reported problems
Seaspine Orthopedics Corporation · GUIDEWIRE, SINGLE SHARP · Class 1
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 10889981212384), received between Mar 31, 2023 and Mar 31, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
- Material Fragmentation1
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.
MalfunctionMar 31, 2023Fracture; Material Fragmentation; Fracture; Material Fragmentation
THE CUSTOMER REPORTED THAT THE MM2-100050 GUIDEWIRE, SINGLE SHARP FRACTURED DURING THE SURGERY RESULTING IN INJURY TO THE PATIENT AND ADDITIONAL INCISION AND DISSECTION TO RETRIEVE BROKEN COMPONENT. REPORT DETAILS BELOW: THE SURGEON WAS CONDUCTING POSTERIOR FUSION OF L4/5, BACKING UP A STAGE 1 L4/5 ALIF. THE SURGEON WAS PLACING FASCIAL SPLITTER WITH ATTACHED BLADE OVER GUIDEWIRE. GUIDEWIRE WAS POSITIONED IN PEDICLE OF VERTEBRAL BODY AND HAD BEEN PLACED UTILISING BRAINLAB NAVIGATION AND BRAINLAB NAVIGATED JAMSHIDI NEEDLE. THE POSITIONING WAS CONFIRMED AND WAS CORRECT AND ACCEPTABLE WITH INTRAOPERATIVE CT. THE FASCIAL SPLITTER APPEARED TO 'CATCH' AND 'FOLD' THE GUIDEWIRE UNDER THE ADVANCING FASCIAL BLADE. THE SURGEON APPEARED TO USE EXTENSIVE DOWNWARD FORCE AND APPEARED TO SEVER GUIDEWIRE. DISTAL SHEARED END OF GUIDEWIRE (APPROXIMATE 50MM) HAS THEN MIGRATED, UNDER EXTREME TENSION TO APPROXIMATE POSITION OF PATIENT'S PSOAS MUSCLE AND HAS EMBEDDED ITSELF THERE. THE INCIDENT WAS OCCURRED WITH EQUIPMENT IN CONTACT WITH THE PATIENT WHICH CAUSED 1.5 HOUR DELAY TO SURGERY WHILST RETRIEVAL OF BROKEN COMPONENT WAS UNDERTAKEN. THIS RESULTED IN INJURY TO PATIENT AND ADDITIONAL INCISION AND DISS
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16659169 ↗
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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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