Erisma®-LP 18156550Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03700780617951), received between Jul 18, 2025 and Jul 18, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Integrity Problem” (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.

• MalfunctionJul 18, 2025Material Integrity Problem; Material Integrity Problem

  THE SURGEON WAS PERFORMING REVISION SURGERY USING THE ERISMA NAVIGATED SYSTEM. WHILE INSERTING A SCREW, THE TULIP HEAD DETACHED FROM THE SCREW. ANOTHER SCREW WAS USED AND INSERTED WITHOUT INCIDENT. ON THE 2ND TRACK OF SCREW REVISIONS, THE TULIP HEAD BECAME DETACHED FROM TWO FURTHER SCREWS. AT THAT POINT, THE SURGEON STOPPED USING THE ERISMA SYSTEM AND COMPLETED THE SURGERY WITH AN ALTERNATIVE SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22546464 ↗

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