HTR-PMI PM622996Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841036282981), received between Apr 3, 2020 and Apr 3, 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.

• MalfunctionApr 3, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THE CUSTOM CRANIAL PLATE WAS TOO LARGE AND HAD TO BE ALTERED INTRAOPERATIVELY PRIOR TO IMPLANTATION. THE CUSTOM PLATE WAS SUCCESSFULLY IMPLANTED ALTHOUGH THE SURGEON DOES NOT BELIEVE THE RESULT IS PERFECT DUE TO THE IMPLANT BEING TOO THICK, ESPECIALLY IN THE FRONTAL AREA. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9920598 ↗

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