NewPort 64-8545Recalls & reported problems
Seaspine Orthopedics Corporation · NewPort Double Lead Screw, 8.5 x 45mm (4mm Hex) · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889981125585), received between Aug 12, 2020 and Aug 12, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Mechanical 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 16, 2026.
Most reported problems
Device problems
- Mechanical Problem1
Patient problems
- Failure of Implant1
- Patient Problem/Medical Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 12, 2020Mechanical Problem; Mechanical Problem
THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2020 DUE TO SUSPECTED INFECTION AND BONE LOSS. THE CONSTRUCT CONSISTED OF SEASPINE'S NEWPORT SPINAL SYSTEM L4-S1. ON (B)(6) 2020, SEASPINE WAS MADE AWARE THAT THE RIGHT S1 NEWPORT DOUBLE LEAD SCREW, 8.5 X 45MM (4MM HEX) (64-8545) HAD DISASSEMBLED IN-SITU 10 DAYS AFTER IT WAS IMPLANTED. ON (B)(6) 2020, THE SURGEON REVISED THE PATIENT, REPLACED THE AFFECTED SCREW, AND INCREASED THE SUPPORT OF THE CONSTRUCT GIVEN THE PATIENT'S PRE-EXISTING ISSUES. THE PATIENT WAS REPORTED TO BE DOING WELL; THERE WERE NO COMPLICATIONS DURING THE REVISION SURGERY AND THE FIXATION AND STABILITY ACHIEVED WAS OPTIMAL FROM A CLINICAL STANDPOINT.
Patient problems: Failure of Implant; Patient Problem/Medical Problem
MAUDE report 10396448 ↗
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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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