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OSTEOSET 87004805Recalls & reported problems

Wright Medical Technology, Inc. · Pellet Injector · 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 00840420133649), received between Aug 10, 2021 and Aug 10, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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

  • Fracture1

Patient problems

  • Foreign Body In Patient1

Recent adverse event reports

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

  • MalfunctionAug 10, 2021Fracture; Fracture

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REDUCTION AND INTERNAL FIXATION OF A FEMORAL SHAFT FRACTURE AND BONE GRAFT SURGERY UNDER GENERAL ANESTHESIA. AFTER INSERTION OF THE ARTIFICIAL BONE GRAFT IT WAS FOUND THAT A PIECE OF THE PLASTIC FROM THE INJECTOR WAS MISSING. THE SURGEON FAILED TO FIND THE BROKEN PIECE AND CLOSED THE WOUND OF THE PATIENT.

    Patient problems: Foreign Body In Patient

    MAUDE report 12302375 ↗

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.