Trestle Luxe 71004-068Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00844856067196), received between Jul 14, 2016 and Jul 14, 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

Recent adverse event reports

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

• MalfunctionJul 14, 2016Break; Detachment Of Device Component; Component Missing

  THE LOCKING SLIDE BROKE OFF TWO SEPARATE 4-LEVEL TRESTLE LUXE PLATES WHILE BENDING. THE SECOND PLATE WAS IMPLANTED BUT A SCREW/ANCHOR WAS NOT INSERTED AT THE LOCATION WHERE THE LOCKING SLIDE WAS MISSING. THE EVENT CAUSED NO PATIENT ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5796308 ↗

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