A.L.P.S.® 8561-35-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00887868352058), received between Nov 2, 2022 and Aug 23, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (9 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 10 most recent of 10 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 50393122 ↗
• MalfunctionNov 10, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED BY THE DISTRIBUTORSHIP THAT THE PRODUCT WAS NONCONFORMING, AS THE STERILE PACKAGE HAD SCRATCH MARKS ON IT. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15770293 ↗
• MalfunctionNov 10, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15770265 ↗
• MalfunctionNov 10, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED BY THE DISTRIBUTORSHIP THAT THE PRODUCT WAS NONCONFORMING, AS THE STERILE PACKAGE HAD SCRATCH MARKS ON IT. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15770262 ↗
• MalfunctionNov 10, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED BY THE DISTRIBUTORSHIP THAT THE PRODUCT WAS NONCONFORMING, AS THE STERILE PACKAGE HAD SCRATCH MARKS ON IT. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15770240 ↗
• MalfunctionNov 10, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED BY THE DISTRIBUTORSHIP THAT THE PRODUCT WAS NONCONFORMING, AS THE STERILE PACKAGE HAD SCRATCH MARKS ON IT. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15770200 ↗
• MalfunctionNov 10, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED BY THE DISTRIBUTORSHIP THAT THE PRODUCT WAS NONCONFORMING, AS THE STERILE PACKAGE HAD SCRATCH MARKS ON IT. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15770199 ↗
• MalfunctionNov 10, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED BY THE DISTRIBUTORSHIP THAT THE PRODUCT WAS NONCONFORMING, AS THE STERILE PACKAGE HAD SCRATCH MARKS ON IT. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15770187 ↗
• MalfunctionNov 10, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED BY THE DISTRIBUTORSHIP THAT THE PRODUCT WAS NONCONFORMING, AS THE STERILE PACKAGE HAD SCRATCH MARKS ON IT. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15770182 ↗
• MalfunctionNov 2, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED BY THE DISTRIBUTORSHIP THAT THE PRODUCT WAS NONCONFORMING, AS THE STERILE PACKAGE HAD SCRATCH MARKS ON IT. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15713987 ↗