SeaSpine Spacer System - Hollywood VI NanoMetalene 34-8112-SRecalls & reported problems
Seaspine Orthopedics Corporation · Hollywood VI NM Sterile 11mm x 27mm x 12mm, Lordotic · Class 2 · Implant
Data updated Oct 18, 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 00889981034811), received between Apr 13, 2020 and Apr 13, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Material Erosion” (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 Erosion1
Patient problems
- Patient Problem/Medical Problem1
- Spinal Column Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 13, 2020Material Erosion; Material Erosion
ON (B)(6) 2020, THE PATIENT UNDERWENT SPINAL SURGERY CONSISTING OF SEASPINE'S INTERVERTEBRAL FUSION DEVICE HOLLYWOOD VI NANOMETALENE. ON (B)(6) 2020, SEASPINE WAS INFORMED OF A REVISION SURGERY DUE TO IMPLANT SUBSIDENCE. UPON REMOVAL, IT WAS OBSERVED THAT THE NANOMETALENE COATING SEPARATED FROM THE IMPLANT.
Patient problems: Patient Problem/Medical Problem; Spinal Column Injury
MAUDE report 9955335 ↗
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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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