Skip to content

BacFuse® 83-00-16Recalls & reported problems

Pioneer Surgical Technology, Inc. · 16mm Spinous Process Fusion Plate, Titanium-Alloy · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00846468047740), received between Jul 27, 2021 and Jul 27, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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 Markings/Labelling Problem1

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.

  • InjuryJul 27, 2021Device Markings/Labelling Problem

    IT WAS REPORTED TO RTI SURGICAL ON (B)(6) 2021 THAT DURING A SURGERY PERFORMED ON (B)(6) 2021, THE SURGEON IMPLANTED A BACFUSE DEVICE AND THEN IMMEDIATELY EXPLANTED IT AFTER REALIZING THAT THE DEVICE WAS PAST ITS EXPIRATION DATE. A NEW DEVICE WITHIN IT'S VALIDATED STERILITY PARAMETERS WAS THEN IMPLANTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12233983 ↗

Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices

All APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices →

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