Trestle Luxe 71004-064Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00844856067189), received between Mar 13, 2017 and Feb 5, 2020 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2020Detachment of Device or Device Component; Material Twisted/Bent

  TWO 64MM PLATES WERE BENT DURING SURGERY AND GOLD PIECES SNAPPED OFF. THE SURGEON INDICATED THAT WHEN HE BENT THE PLATES, THE GOLD SLIDES DID NOT COME OFF UNTIL INSERTING THE SCREWS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9672072 ↗
• InjuryNov 30, 2018Material Protrusion/Extrusion

  DURING A REVISION CASE, THE SURGEON PLACED ALL SCREWS INTO PLATE. ONE OF THE SCREWS WENT THROUGH THE PLATE CAUSING REMOVAL OF THE ENTIRE CONSTRUCT. THE EVENT CAUSED THE SURGERY TO BE DELAYED APPROXIMATELY 1.5 TO 2 HOURS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8120883 ↗
• InjuryMar 13, 2017Device Operates Differently Than Expected

  WHILE INSERTING A 4-LEVEL TRESTLE LUXE PLATE ONE OF THE SELF-TAPPING SCREWS PASSED COMPLETELY THRU THE PLATE. THE PLATE WAS REMOVED AND REPLACED WITH A NEW 3-LEVEL PLATE AT WHICH TIME THE RESCUE SCREW ALSO PASSED COMPLETELY THRU THIS NEWLY IMPLANTED PLATE. THE RESCUE SCREW WAS REMOVED FROM THE PATIENT WHILE THE 3-LEVEL TRESTLE LUXE PLATE REMAINS SECURED WITHIN THE PATIENT'S CERVICAL SPINE. REMOVAL AND REPLACEMENT OF THE IMPLANTS CAUSED A 30-40 MINUTE DELAY IN THE CASE.

  Patient problems: No Code Available

  MAUDE report 6401290 ↗

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 · Terminated
  4.0mm 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 · Terminated
  TRESTLE 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