A.L.P.S.® 8561-35-014Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00887868351822), received between Apr 8, 2021 and Aug 25, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 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 50430424 ↗
• 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 50430337 ↗
• 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 50430320 ↗
• InjuryAug 21, 2025Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Aseptic loosening; Skin Discoloration

  MAUDE report 22862399 ↗
• MalfunctionApr 8, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11633512 ↗