Anterior Lumbar Plate System ALP-35HSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840019925556), received between Mar 29, 2021 and Mar 29, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Deformation” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 29, 2021Break; Material Deformation

  IT WAS REPORTED THAT AN ANTERIOR LUMBAR PLATE PROCEDURE WAS PERFORMED ON (B)(6) 2021, UTILIZING THE ACCUFIT ALIF PLATE SYSTEM. WHILE PLACING A SCREW THE TIP OF TWO ALP 3.5 HEX SCREWDRIVER SHAFTS (ALP-35HS) STRIPPED ALONG WITH THE HEAD OF THE SCREW. THE STRIPPED SCREW WAS REMOVED AND REPLACED UTILIZING OTHER INSTRUMENTATION READILY AVAILABLE. THERE WAS NO HARM TO THE PATIENT, BUT A TWO (2) MINUTE DELAY BECAUSE OF THE DRIVER TIP FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11581577 ↗
• InjuryMar 29, 2021Device Damaged by Another Device; Material Deformation

  IT WAS REPORTED THAT AN ANTERIOR LUMBAR PLATE PROCEDURE WAS PERFORMED ON (B)(6), 2021, UTILIZING THE ACCUFIT ALIF PLATESYSTEM. WHILE PLACING A SCREW THE TIP OF TWO ALP 3.5 HEX SCREWDRIVER SHAFTS (ALP-35HS) STRIPPED ALONG WITH THE HEAD OF THE SCREW. THE STRIPPED SCREW WAS REMOVED AND REPLACED UTILIZING OTHER INSTRUMENTATION READILY AVAILABLE. THERE WAS NO HARM TO THE PATIENT, BUT A TWO (2) MINUTE DELAY BECAUSE OF THE DRIVER TIP FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11581576 ↗