A.L.P.S.DISTAL TIBIA MEDIAL LOCKING PLATE 8562-10-009Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887868062056), received between Nov 11, 2022 and Aug 25, 2026 — classified as 1 injury, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that after fixation with a plate system, erythema and purulent drainage developed around the plate and the patient reported discomfort; the plate was subsequently removed approximately five months post-implantation. Concerns were raised by sales and dealership staff regarding the hospital¿s sterilization and cleaning facilities; however, the validity of these concerns was unclear.Attempts have been made and no further information has been provided.

  Patient problems: Discomfort; Erythema; Purulent Discharge

  MAUDE report 50429928 ↗
• 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 15779112 ↗
• 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 15779103 ↗