MEDPOR 9526Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613252086031), received between Mar 1, 2019 and Mar 1, 2019 — classified as 1 injury.

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

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 1, 2019Unsealed Device Packaging; Component Missing

  IT WAS REPORTED BY A CIRCULATING NURSE THAT DURING A MEDICAL PROCEDURE TO PLACE AN IMPLANT WHEN OPENING THE IMPLANT CONTAINER IT WAS FOUND THE SEAL HAD BROKEN AND THE CONTAINER WAS EMPTY. A REVISION SURGERY HAD TO BE PLANNED TO COMPLETE THE PROCEDURE.

  Patient problems: No Information

  MAUDE report 8383102 ↗

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