Skip to content

PROCOTYL® PRIME P3FDB420Recalls & reported problems

Microport Orthopedics Inc. · Class 1

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 M684P3FDB4201), received between Jan 9, 2023 and Jan 9, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Use of Device 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

  • Use of Device Problem1

Patient problems

  • Metal Related Pathology1

Recent adverse event reports

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

  • InjuryJan 9, 2023Use of Device Problem; Use of Device Problem

    ALLEGEDLY, TROUBLESHOOTING: 4.0 MM X 20 MM DRILL AND THE DRILL GUIDE WAS USED TO MAKE A SCREW HOLE FOR THE PLACEMENT OF A PRIME CUP FIXATION SCREW. DURING THIS PROCEDURE, A BLOOD VESSEL WAS INJURED AND BLEEDING WAS OBSERVED POSTOPERATIVELY. THIS WAS CONSIDERED A TECHNICAL ERROR BY THE DR. SURGEON'S FINDING: CONSIDERED A TECHNICAL ERROR BY THE SURGEON. FINDINGS OF THE REPORTER AND STATUS OF RESPONSE: HP AND THE PATIENT HAD A PROBLEM, AND HP ASKED FOR A DOCUMENT SHOWING THE SHAPE OF THE SCREW DRILL ?P3FDB420 PRIME FLEXIBLE DRILL BIT 4.0 X 20MM? (B)(4).

    Patient problems: Metal Related Pathology

    MAUDE report 16122660 ↗

Other BIT, SURGICAL devices

All BIT, SURGICAL devices →

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