A.L.P.S.DISTAL TIBIA MEDIAL LOCKING PLATE 8562-11-006Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887868062087), received between Nov 11, 2022 and Nov 11, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Unsealed Device Packaging” (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.

• MalfunctionNov 11, 2022Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED DURING THE INCOMING INSPECTION AT WAREHOUSE THAT THE STERILE PACKAGE WAS NOT VACUUMED. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15779108 ↗
• MalfunctionNov 11, 2022Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED DURING THE INCOMING INSPECTION AT WAREHOUSE THAT THE STERILE PACKAGE WAS NOT VACUUMED. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15779106 ↗