MEDPOR 82007Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613252084716), received between May 31, 2019 and Jun 5, 2019 — classified as 4 injuries.

1 other recall cover devices cleared under the same FDA submission (K922489); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 5, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS NOTED THROUGH A MEDICAL PUBLICATION THAT DURING A COLLATERAL MATERIAL REVIEW AN ADVERSE EVENT OCCURRED AFTER THE COMPLETION OF A SURGICAL PROCEDURE. THE STUDY INDICATES ONE COMPLAINT OF TENSION PNEUMOCEPHALUS REQUIRING OPERATIVE DECOMPRESSION. NO OTHER INFORMATION IS KNOWN.

  Patient problems: No Code Available

  MAUDE report 8670626 ↗
• InjuryMay 31, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS NOTED THROUGH A MEDICAL PUBLICATION THAT DURING A COLLATERAL MATERIAL REVIEW AN ADVERSE EVENT OCCURRED AFTER THE COMPLETION OF A SURGICAL PROCEDURE. THE STUDY INDICATES ONE COMPLAINT OF EPISTAXIS. NO OTHER INFORMATION IS KNOWN.

  Patient problems: No Code Available

  MAUDE report 8659628 ↗
• InjuryMay 31, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS NOTED THROUGH A MEDICAL PUBLICATION DURING A COLLATERAL MATERIAL REVIEW THAT SUBDURAL HEMATOMA OCCURRED AFTER THE COMPLETION OF A PROCEDURE INVOLVING THE USE OF A TRANSSPHENOIDAL SELLAR IMPLANT. THE STUDY INDICATES 1 CASE OF ASEPTIC MENINGITIS. NO OTHER INFORMATION IS KNOWN.

  Patient problems: Hematoma; Meningitis

  MAUDE report 8659493 ↗
• InjuryMay 31, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS NOTED THROUGH A MEDICAL PUBLICATION DURING A COLLATERAL MATERIAL REVIEW THAT A CASE OF ASEPTIC MENINGITIS OCCURRED AFTER THE COMPLETION OF A SURGICAL PROCEDURE INVOLVING THE USE OF A TRANSSPHENOIDAL SELLAR IMPLANT. THE STUDY INDICATES 1 CASE OF ASEPTIC MENINGITIS OCCURRED. NO OTHER INFORMATION IS KNOWN.

  Patient problems: Meningitis

  MAUDE report 8659490 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K922489. One submission often covers many models, so check the product and lot details in each record.

• Z-1090-2015 · Dec 17, 2014 · Terminated
  MEDPOR Surgical Implant Contoured Two Piece Chin 5 mm; Part Number 86001; Lot Numbers A1405048, A1404026 Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are i