HTR-PMI PM623210-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888233026000), received between Aug 31, 2020 and Aug 31, 2020 — classified as 1 injury.

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.

• InjuryAug 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A CUSTOM CRANIOPLASTY PLATE WAS REMOVED DUE TO NECROSIS TWO (2) MONTHS AFTER IMPLANTATION. A FEW DAYS AFTER SURGERY, A BRUISE WAS OBSERVED IN THE SKIN OVER THE MIDDLE OF THE IMPLANT, AND THE BRUISE DID NOT IMPROVE. TWO (2) WEEKS PRIOR TO REMOVAL, THE SPOT ON THE SKIN OPENED UP WITH FLUID ESCAPING. IT HAS NOT BEEN DETERMINED IF THE BACK-UP IMPLANT WILL BE USED OR IF A NEW CUSTOM PLATE WILL BE IMPLANTED IN THE COMING MONTHS. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Bruise/Contusion; Fluid Discharge; Necrosis

  MAUDE report 10475092 ↗

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