A.L.P.S.® 8562-07-004Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887868445996), received between Sep 9, 2022 and Aug 28, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Mechanical Jam” (1 report).

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.

• InjuryAug 28, 2026Mechanical Jam

  It was reported that during an initial fixation procedure, a screw guide became stuck to the plate and the screwdriver tip fractured during attempted removal. To confirm the screw insertion direction, the guide had been reattached to the plate. When removal was attempted, the guide could not be released using a screwdriver. Increased force was applied, causing the screwdriver tip to break, with a fragment remaining inside the guide. The guide could not be removed, and the procedure was completed with the guide still attached to the plate.Attempts have been made and no further information has been provided.

  Patient problems: Foreign Body In Patient

  MAUDE report 50506619 ↗
• MalfunctionSep 9, 2022Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE PRODUCT HAD A HAIR-LIKE SUBSTANCE WAS FOUND ON THE STERILE PACKAGE. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15391593 ↗