A.L.P.S.® 8561-35-065Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00887868352065), received between Aug 23, 2026 and Aug 23, 2026 — classified as 5 injuries.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that following an initial fixation procedure on the tibia for a tibial plateau fracture, redness, a rash, and a fistula were observed at the surgical site and the patient reported discomfort. An infection was reported, and a metal allergy was suspected. At five months following implantation, the construct was removed and an artificial bone block was placed. Following the construct explantation, the fistula closed and the clinical course was reported to be without problems. Attempts have been made and no further information has been provided.

  Patient problems: Discomfort; Erythema; Fistula; Hypersensitivity/Allergic reaction; Medical device site infection; Rash

  MAUDE report 50393127 ↗
• InjuryAug 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that following an initial fixation procedure on the tibia for a tibial plateau fracture, redness, a rash, and a fistula were observed at the surgical site and the patient reported discomfort. An infection was reported, and a metal allergy was suspected. At five months following implantation, the construct was removed and an artificial bone block was placed. Following the construct explantation, the fistula closed and the clinical course was reported to be without problems. Attempts have been made and no further information has been provided.

  Patient problems: Discomfort; Erythema; Fistula; Hypersensitivity/Allergic reaction; Medical device site infection; Rash

  MAUDE report 50393126 ↗
• InjuryAug 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that following an initial fixation procedure on the tibia for a tibial plateau fracture, redness, a rash, and a fistula were observed at the surgical site and the patient reported discomfort. An infection was reported, and a metal allergy was suspected. At five months following implantation, the construct was removed and an artificial bone block was placed. Following the construct explantation, the fistula closed and the clinical course was reported to be without problems. Attempts have been made and no further information has been provided.

  Patient problems: Discomfort; Erythema; Fistula; Hypersensitivity/Allergic reaction; Medical device site infection; Rash

  MAUDE report 50393125 ↗
• InjuryAug 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that following an initial fixation procedure on the tibia for a tibial plateau fracture, redness, a rash, and a fistula were observed at the surgical site and the patient reported discomfort. An infection was reported, and a metal allergy was suspected. At five months following implantation, the construct was removed and an artificial bone block was placed. Following the construct explantation, the fistula closed and the clinical course was reported to be without problems. Attempts have been made and no further information has been provided.

  Patient problems: Discomfort; Erythema; Fistula; Hypersensitivity/Allergic reaction; Medical device site infection; Rash

  MAUDE report 50393124 ↗
• InjuryAug 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that following an initial fixation procedure on the tibia for a tibial plateau fracture, redness, a rash, and a fistula were observed at the surgical site and the patient reported discomfort. An infection was reported, and a metal allergy was suspected. At five months following implantation, the construct was removed and an artificial bone block was placed. Following the construct explantation, the fistula closed and the clinical course was reported to be without problems. Attempts have been made and no further information has been provided.

  Patient problems: Discomfort; Erythema; Fistula; Hypersensitivity/Allergic reaction; Medical device site infection; Rash

  MAUDE report 50393120 ↗