Trestle Luxe 71002-034Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00844856067011), received between Mar 1, 2017 and Nov 18, 2020 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2020Break

  UPON USING THE PLATE BENDING, THE LOCKING MECHANISM BROKE OFF THE PLATE.

  Patient problems: Insufficient Information

  MAUDE report 10861201 ↗
• InjuryAug 10, 2020Detachment of Device or Device Component; Material Protrusion/Extrusion

  REVISION SURGERY WAS CONDUCTED ON (B)(6) 2020 TO REMOVE AND REPLACE A 2-LEVEL TRESTLE LUXE PLATE. THE LOCKING MECHANISM BECAME DETACHED WHICH ALLOWED THE SCREW TO PROTRUDE. THE TRESTLE LUXE ANTERIOR CERVICAL PLATING SYSTEM WAS INITIALLY IMPLANTED ON (B)(6) 2020.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10385413 ↗
• MalfunctionApr 24, 2019Device Dislodged or Dislocated; Material Twisted/Bent

  THE GOLD PIECE IN THE CENTER OF THE PLATE POPPED OFF AFTER BENDING TO ACHIEVE ADDITIONAL LORDOSIS. NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8544614 ↗
• MalfunctionApr 24, 2019Device Dislodged or Dislocated; Material Twisted/Bent

  THE GOLD PIECE IN THE CENTER OF BOTH PLATES POPPED OFF AFTER BENDING EACH OF THEM TO ACHIEVE ADDITIONAL LORDOSIS. AN ADDITIONAL PLATE WAS ALSO BENT TO FIT THE PATIENT. THE GOLD PIECE POPPED OFF THIS ONE AS WELL, BUT THE SURGEON ELECTED TO INSTALL THE PLATE WITHOUT A LOCKING MECHANISM. THE EVENT CAUSED NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8544492 ↗
• MalfunctionApr 24, 2018Device Dislodged or Dislocated

  THE SURGEON GRASPED A PLATE WITH PLATE HOLDER AND AS HE WAS TRYING IT IN PATIENT, ONE OF THE LOCKING SLIDES POPPED OFF. SURGEON INSTALLED THE PLATE WITHOUT A LOCKING MECHANISM AT THAT POSITION, LEAVING THE HOLE EMPTY (C6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7454600 ↗
• MalfunctionMar 1, 2017Detachment Of Device Component; Component Falling; Use of Device Problem

  DURING THE CASE, A TRESTLE LUXE 2-LEVEL PLATE WAS RENDERED USELESS AS THE MIDDLE "LOCKING BAR" FELL OUT AS THE SURGEON ATTEMPTED TO BEND THE PLATE. THERE WERE NO PATIENT COMPLICATIONS. A SECOND 34MM PLATE WAS SELECTED, BENT APPROPRIATELY AND IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6370041 ↗

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