A.L.P.S.® 8512-35-016Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887868352409), received between Jul 21, 2021 and Aug 25, 2026 — classified as 2 injuries, 2 malfunctions.

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. 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 4 most recent of 4 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 50429997 ↗
• 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 removedapproximately 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 concernswas unclear.Attempts have been made and no further information has been provided.

  Patient problems: Discomfort; Erythema; Purulent Discharge

  MAUDE report 50429920 ↗
• MalfunctionMar 17, 2022Fracture; Fracture

  IT WAS REPORTED DURING SURGERY, THE SCREW HEAD CRACKED AS THE SURGEON WAS TIGHTENING IT DURING INSERTION. THE SCREW WAS UNABLE TO BE REMOVED; HOWEVER, IT WAS NOTED THERE SEEMS TO BE NO PROBLEM WITH THE FIXATION OF THE PLATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13802118 ↗
• MalfunctionJul 21, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING INSPECTION IN WAREHOUSE PRODUCT WAS FOUND TO HAVE A STAIN IN THE STERILE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12202527 ↗