SeaSpine Spacer System - Hollywood VI NanoMetalene 34-9110-SRecalls & reported problems
Seaspine Orthopedics Corporation · Hollywood VI NM Sterile 11mm x 30mm x 10mm, 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 00889981064603), received between Jun 23, 2021 and Jun 23, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Osseointegration 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
- Osseointegration Problem1
- Patient Device Interaction Problem1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 23, 2021Osseointegration Problem; Patient Device Interaction Problem; Osseointegration Problem; Patient Device Interaction Problem
ON (B)(6) 2021, THE PATIENT UNDERWENT SPINAL SURGERY CONSISTING OF SEASPINE'S INTERVERTEBRAL FUSION DEVICE HOLLYWOOD VI NANOMETALENE AND GLOBUS' KINEX BONE GRAFT. ON (B)(6) 2021, SEASPINE WAS INFORMED OF A REVISION SURGERY DUE TO PSEUDARTHROSIS. IT WAS REPORTED THAT THE SAME DEVICES WERE IMPLANTED IN THE ADJACENT LEVEL WHICH FUSED AS INTENDED. ADDITIONALLY, UPON REMOVAL OF THE HOLLYWOOD VI NANOMETALENE INTERBODY, IT WAS OBSERVED THAT PORTIONS OF THE NANOMETALENE COATING WAS REMOVED FROM THE PEEK INTERBODY.
Patient problems: Failure of Implant
MAUDE report 12055368 ↗
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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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