Trestle Luxe 71540-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00844856067905), received between Apr 11, 2017 and May 20, 2020 — classified as 3 injuries.

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 16, 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.

• InjuryMay 20, 2020Break

  ALPHATEC LEGAL RECEIVED A PRODUCT LIABILITY CLAIM ON APRIL 23, 2020. THE CLAIM ALLEGES THAT TWO YEAR POST-OP IMAGES REVEALED THE BOTTOM TWO SCREWS HAS SNAPPED AND THE C7 VERTEBRAE WAS FLOATING AROUND IN THE PATIENTS NECK. THE PATIENT INITIALLY UNDERWENT SURGERY ON (B)(6) 2016 FOLLOWING A CRUSH INJURY TO HIS C4, C5, C6 AND C7. THE ALPHATEC TRESTLE LUXE PLATING SYSTEM WAS UTILIZED DURING THE ANTERIOR FUSION. 3, 6 AND 12 MONTH POST-OP VISITS DID NOT DISPLAY ANY CONCERN. ON (B)(6) 2019 DURING A 2 YEARS POST-OP VISIT, X-RAYS APPEARED TO SHOW THAT THE BOTTOM 2 HAD SNAPPED. REVISION SURGERY WAS CONDUCTED ON (B)(6) 2019 IN WHICH ADDITIONAL HARDWARE WAS INSTALLED AT THE C4 THRU T2.

  Patient problems: No Code Available

  MAUDE report 10074444 ↗
• InjuryFeb 24, 2020Device Slipped; Material Protrusion/Extrusion

  TWO MONTH POST-OP IMAGES REVEALED A TRESTLE LUXE SCREW HAD BACKED OUT OF POSITION. REVISION SURGERY WAS CONDUCTED (B)(6) 2020 TO REMOVE AND REPLACE ONLY THE PROTRUDING ANCHOR. THE TRESTLE LUXE PLATING SYSTEM WAS ORIGINALLY IMPLANTED ON (B)(6) 2019 DURING 3-LEVEL ACDF (ANTERIOR CERVICAL DISCECTOMY & FUSION) CASE.

  Patient problems: No Code Available

  MAUDE report 9745414 ↗
• InjuryApr 11, 2017Detachment Of Device Component

  POST OP X-RAYS TAKEN ON (B)(6) 2016 FOUND THE TRESTLE LUXE SCREW LOCATED ON THE LEFT SIDE OF THE C6 CERVICAL VERTEBRAE HAD BACKED OUT PAST LOCKING MECHANISM. REVISION SURGERY WAS CONDUCTED ON (B)(6) 2017. THE TRESTLE LUXE ANTERIOR CERVICAL PLATING SYSTEM WAS ORIGINALLY IMPLANTED ON (B)(6) 2016 DURING AN ACDF (ANTERIOR CERVICAL DISCECTOMY FUSION) FROM C4 THRU C6.

  Patient problems: No Information

  MAUDE report 6482501 ↗

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