Skip to content

PRO-STIM 86SR0410Recalls & 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 00840420143143), received between Mar 13, 2023 and Mar 13, 2023 — 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

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionMar 13, 2023Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

    IT WAS REPORTED THAT THE BONE GRAFT HARDENED AND WAS NOT ABLE TO BE INJECTED IN THE PATIENT. STEP BY STEP DIRECTIONS WERE FOLLOWED BASED ON SURGICAL TECHNIQUE BUT THE TECH WAS HAVING A HARD TIME DOING EVERYTHING IN A TIMELY MANNER. A SECOND KIT WAS OPENED TO TREAT THE PATIENT. THIS WAS A DELAY IN SURGERY OF APPROXIMATELY 5 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT OR THE SURGERY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16530328 ↗

Other Filler, bone void, osteoinduction (w/o human growth factor) devices

All Filler, bone void, osteoinduction (w/o human growth factor) devices →

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