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PRO-DENSE 87SR0420Recalls & reported problems

Wright Medical Technology, Inc. · Injectable · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840420137296), received between Dec 30, 2021 and Dec 30, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Device Difficult to Setup or Prepare1

Patient problems

  • Insufficient Information1

Recent adverse event reports

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

  • MalfunctionDec 30, 2021Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

    THE HOSPITAL STAFF DID NOT MIX THE PRODUCT SUCCESSFULLY AND THE DOCTOR REQUESTED WE DO NOT CHARGE THE PATIENT FOR THIS ITEM AS IT WAS NOT USED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Patient problems: Insufficient Information

    MAUDE report 13122191 ↗

Other FILLER, BONE VOID, CALCIUM COMPOUND devices

All FILLER, BONE VOID, CALCIUM COMPOUND devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.