Erisma®-LP 18911040Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03700780625239), received between May 20, 2022 and May 20, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (1 report).

1 other recall cover devices cleared under the same FDA submission (K153326); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2022Material Fragmentation; Material Fragmentation

  THE TIPS OF THE ERISMA DRIVERS BROKE OFF WHILE THE DR. INSERTING THE REDUCTION AND SIMULTANEOUSLY PULLING LATERALLY TO RETRACT TISSUE. THE SAME ACTION BROKE TWO DRIVERS IN THE PERIOD OF 5 MINUTES. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14454753 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K153326. One submission often covers many models, so check the product and lot details in each record.

• Z-1986-2019 · Jul 1, 2019 · Terminated
  Erisma- LP posterior fixation system with the below specifically affected products: 1. Erisma-LP polyaxial screws - 4.5, 5.5, 6.5, 7.5, 8.5, 9.5, 105 mm (all lengths); 2. Eri