Trestle Luxe 71001-022Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00844856066939), received between Jan 10, 2017 and Jan 10, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment Of 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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 10, 2017Detachment Of Device Component

  DURING THE SURGERY, WHEN INSERTING THE SCREW, THE BLOCKING SLIDE CAME OFF THE PLATE. THE BONE CONDITION OF THE PATIENT WAS NOT BAD, ONLY THE PLATE WAS IMPLANTED AT THE DOCTOR'S DISCRETION. NO HEALTH INJURY OF THE PATIENT IS CONFIRMED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6237032 ↗

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