NA 5444-0-300Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613252133575), received between Jan 7, 2020 and Jan 7, 2020 — classified as 1 injury.

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

1 other recall cover devices cleared under the same FDA submission (K103010); 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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 7, 2020Crack; Crack

  IT WAS REPORTED THAT POST-OP A PATIENT PRESENTED WITH A CSF LEAK AND A REVISION SURGERY WAS PERFORMED. DURING THE REVISION, IT WAS NOTICED THAT THE PMMA CUSTOMIZED IMPLANT HAD CRACKED. THE IMPLANT WAS REMOVED, RE-POSITIONED AND RE-IMPLANTED. THE DOCTOR WAS HAPPY WITH THE FIT. THERE ARE NO POST-OP SCANS FROM EITHER PROCEDURE TO REFERENCE. UPDATE 16/DECEMBER/2019: AS REPORTED IN THE COMMUNICATION LOG: THE SALES REP SPOKE TO DR. AND SHE BELIEVES THE CRACK WAS DUE TO TRAUMA. THE SURGERY WAS TO REPAIR A CSF LEAK AND WHILE MAKING THE EXPOSURE, THEY NOTICED THE CRACK. SHE SUSPECTS THE TWO, CRACK AND CSF LEAK, WERE RELATED.

  Patient problems: Cerebrospinal Fluid Leakage; Injury

  MAUDE report 9560312 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103010. One submission often covers many models, so check the product and lot details in each record.

• Z-0975-2014 · Dec 6, 2013 · Terminated
  Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2) 5444-01-102 Host Bone; Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA. Designed in