Trestle Luxe 71540-13Recalls & reported problems
Alphatec Spine, Inc. · 4.0mm Fixed Angle, Self-Tapping Hexalobe Screw, 13mm · Class 2 · Implant
All models of Trestle Luxe (24)
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 00844856067875), received between Jul 20, 2016 and Jul 20, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K102820); they may or may not involve this specific model.
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
- Break1
- Loose or Intermittent Connection1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 20, 2016Break; Loose or Intermittent Connection
PATIENT CONTACTED ALPHATEC DIRECTLY ALLEGING BROKEN HARDWARE IN HER CERVICAL SPINE. ONE OF THE SCREWS IN HER NECK HAS BROKEN AS WELL AS ONE HAS COME LOOSE. SHE IS LOOKING FOR INFORMATION REGARDING THIS ISSUE. THE TRESTLE LUXE ANTERIOR CERVICAL PLATING SYSTEM WAS ORIGINALLY IMPLANTED ON (B)(6) 2015. NO OTHER INFORMATION HAS BEEN PROVIDED OR IS KNOWN AT THIS TIME.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5809380 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K102820. One submission often covers many models, so check the product and lot details in each record.
- Z-1547-2015 · Apr 10, 2015 · Terminated4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm Alphatec Spine Solutions for the Aging Spine Trestle Luxe Anterior Cervical Plating System REF 71240-14 LOT XXXXXX Alphat
- Z-2273-2012 · May 29, 2012 · TerminatedTRESTLE LUXE Anterior Cervical Plating System, Product code KWQ. 510(k) K102820. The TRESTLE LUXE Anterior Cervical Plating System is a temporary device used to stabilize the cerv
Other APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY devices
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- EVEREST® Spinal System 2901-10001VB Spine LLC · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY119 reports
- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- XLP 7565050Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430344Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- ATLANTIS® Anterior Cervical Plate System 876-170Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- XLP 7565060Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430113Clariance · Appliance, Fixation, Spinal Intervertebral Body1 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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