NewPort 91-8206Recalls & reported problems
Seaspine Orthopedics Corporation · Large Dilator · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10889981083120), received between Jan 11, 2019 and Sep 18, 2019 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (3 reports).
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 16, 2026.
Most reported problems
Device problems
- Break3
Patient problems
- Failure of Implant2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2019Break; Break
ON (B)(6) 2018, THE PATIENT HAD THE MARINER PEDICLE SCREW SYSTEM PLACED AT L4-S1 IN ADJUNCT TO A NON-SEASPINE INTERBODY IMPLANT. ON (B)(4) 2019, SEASPINE WAS MADE AWARE THAT THE PATIENT HAD EXPERIENCED TWO BROKEN SOLID SCREWS POST-OPERATIVELY, THAT HAD BEEN PLACED BILATERALLY AT S1. X-RAY IMAGES WERE PROVIDED WHICH SHOWED THE SCREWS HAD BROKEN AT THE NECK. ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION SURGERY AND THE BROKEN SCREWS WERE REPLACED. NO ADDITIONAL EVENT INFORMATION WAS PROVIDED.
Patient problems: Failure of Implant
MAUDE report 9083978 ↗InjurySep 18, 2019Break; Break
ON (B)(6) 2018, THE PATIENT HAD THE MARINER PEDICLE SCREW SYSTEM PLACED AT L4-S1 IN ADJUNCT TO A NON-SEASPINE INTERBODY IMPLANT. ON (B)(6) 2019, SEASPINE WAS MADE AWARE THAT THE PATIENT HAD EXPERIENCED TWO BROKEN SOLID SCREWS POST-OPERATIVELY, THAT HAD BEEN PLACED BILATERALLY AT S1. X-RAY IMAGES WERE PROVIDED WHICH SHOWED THE SCREWS HAD BROKEN AT THE NECK. ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION SURGERY AND THE BROKEN SCREWS WERE REPLACED. NO ADDITIONAL EVENT INFORMATION WAS PROVIDED.
Patient problems: Failure of Implant
MAUDE report 9083977 ↗MalfunctionJan 11, 2019Break; Break
ON (B)(6) 2018, THE PATIENT UNDERWENT A ONE LEVEL TLIF PROCEDURE WITH THE NEWPORT SYSTEM. DURING THE PROCEDURE, A PIECE OF THE DISTAL TIP OF THE LARGE DILATOR BROKE OFF IN-SITU. THE INCISION WAS EXPLORED THOROUGHLY BUT THE BROKEN PIECE WAS UNABLE TO BE LOCATED. IT WAS INDICATED THAT THE BROKEN PIECE COULD HAVE FALLEN OFF THE FIELD, BEEN SUCTIONED UP OR FRAGMENTS COULD HAVE REMAINED WITHIN THE PATIENT'S SOFT TISSUE. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A BACK-UP DILATOR AND A REVISION SURGERY WAS NOT PLANNED. NO FURTHER EVENT INFORMATION IS AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8241917 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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