SeaSpine Spacer System - Hollywood™ 34-8009Recalls & reported problems
Seaspine Orthopedics Corporation · Hollywood VI Implant, 11mm x 27mm x 9mm, Lordotic · Class 2
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 10889981034542), received between Mar 14, 2016 and Mar 14, 2016 — 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
- Mechanical Problem1
Patient problems
- Incontinence1
- Neurological Deficit/Dysfunction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 14, 2016Fracture; Mechanical Problem; Fracture; Mechanical Problem
(B)(4). EVENT DESC: DURING THE TLIF OPERATIVE PROCEDURE ON (B)(6) 2013, FRAGMENTS OF THE PEEK CAGE BROKE OFF WHILE INSERTING INTERBODY CAGE AT L4-L5. THE SURGEON THEN PULLED THE ENTIRE CAGE BACK OUT AS WELL AS THE PIECE THAT BROKE OFF. SURGEON REPORTEDLY ELECTED TO RE-INSERT THE CAGE WITHOUT THE MISSING FRAGMENT. THE CONDITION OF THE IMPLANT UPON RE-INSERTION IS UNKNOWN OR HOW BIG A PIECE HAD BROKEN OFF. THE PATIENT REPORTS HERSELF TO BE INCONTINENT AND HAS FOOT DROP. IT IS UNDETERMINED IF THE ALLEGATION OF INCONTINENCES AND FOOT DROP IS THE RESULT OF THE INITIAL INSERTION OF THE CAGE OR EXPLORATION AND REMOVAL OF THE FRAGMENT OR OTHERWISE A RESULT OF THE OVERALL PROCEDURE ITSELF. THE ORIGINAL INTENT OF THE PROCEDURE WAS: LUMBAR LAMINECTOMY. LUMBER DISCECTOMY. LUMBAR SPINAL FUSION. LEFT TRANSFORMINAL LUMBER INTERBODY FUSION TLIF. L4-L5 WITH INSERTERTION PEEK A CAGE, BILATERAL POSTOLATERAL PEDICLE SCREW INSTRUMENTATION WITH ROD EXCHANGE. NO OTHER INFORMATION GIVEN. IT IS UNKNOWN WHAT HAS BEEN DONE TO CORRECT THE ISSUE. THE REASON FOR THE 2 YEAR DELAY IN REPORTING IS UNKNOWN.
Patient problems: Incontinence; Neurological Deficit/Dysfunction
MAUDE report 5499569 ↗
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- X-CORE 7180016Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 18-22 mm, 2-5 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 23-32 mm, 2-5 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
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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