HTR-PMI PM623462Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888233029155), received between Oct 8, 2020 and Oct 8, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (1 report).

1 other recall cover devices cleared under the same FDA submission (K924935); 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.

• MalfunctionOct 8, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THE CUSTOM CRANIOPLASTY PLATE WAS TOO SMALL AND DID NOT FIT AS DESIRED. THE SURGEON HAD TO USE BONE CEMENT IN THE CAUDAL AREA OF THE DEFECT IN ORDER TO COMPLETELY REPAIR THE DEFECT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10653586 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K924935. One submission often covers many models, so check the product and lot details in each record.

• Z-2751-2016 · Jun 13, 2016 · Terminated
  Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made. HTR polymer implants are intended for bone replacement/augmentation for treatment of