Gallery™ Laminoplasty System 14-523101Recalls & reported problems
Biomet Spine LLC · 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 00880304960343), received between Nov 14, 2024 and Nov 14, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Wrong Label” (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.
Reports received per month
Most reported problems
Device problems
- Wrong Label1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 14, 2024Wrong Label; Wrong Label
IT WAS REPORTED THAT A PACKAGED 2.4 MM GALLERY SCREW WAS LABELED AS A 2.8 MM GALLERY SCREW. THIS WAS FOUND DURING INSPECTION AFTER IT WAS RETURNED FROM THE FIELD SO THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20684731 ↗
Other ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL devices
- Centerpiece Plate Fixation System 8532065Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL13 reports
- Centerpiece Plate Fixation System 8532067Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL11 reports
- Xspan Laminoplasty Fixation System X085-0250-STRXtant Medical Holdings, Inc. · ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL6 reports
- Xspan Laminoplasty Fixation System X085-0150-STRXtant Medical Holdings, Inc. · ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL3 reports
- Centerpiece Plate Fixation System G8532067Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL3 reports
- ESCALATE 48570300Stryker Corporation · ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL2 reports
- CANOPY 1102.1005Globus Medical, Inc. · ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL1 report
- CANOPY 1102.4011Globus Medical, Inc. · ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL1 report
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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