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NA 1011-40-045Recalls & reported problems

Depuy Orthopaedics, Inc. · SELF TAPPING ROOF PILE SCREW 45mm · Class 2 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295000471), received between Jan 11, 2019 and Feb 26, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Osseointegration 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

  • Adverse Event Without Identified Device or Use Problem1
  • Osseointegration Problem1
  • Unintended Movement1

Patient problems

  • No Code Available2
  • Hemorrhage/Blood Loss/Bleeding1
  • Unspecified Infection1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 26, 2020Osseointegration Problem; Unintended Movement; Osseointegration Problem; Unintended Movement

    PPF AND STICKER SHEETS RECEIVED. THERE WERE NO ALLEGATIONS REPORTED HOWEVER THE PATIENT WAS REVISED AND THE REASON FOR REVISION WAS NOT PROVIDED. DOI: (B)(6) 2017. DOR: (B)(6) 2018, (LEFT HIP, FIFTH REVISION).

    Patient problems: Hemorrhage/Blood Loss/Bleeding; No Code Available

    MAUDE report 9753111 ↗
  • InjuryJan 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PFS ALLEGES INFECTION, DISLOCATION, MUSCLE DAMAGE AND ANEMIA. AFTER THE REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY, PATIENT WAS REVISED TO ADDRESS DISLOCATION, STATUS POST COMPLEX RIGHT REVISION. REVISION NOTES REPORTED OF ANTERIOR DISLOCATION. CLINICAL NOTES REPORTED OF STAPH INFECTION AND PURULENT DRAINAGE.

    Patient problems: No Code Available; Unspecified Infection

    MAUDE report 8239739 ↗

Other Mesh, surgical, acetabular, hip, prosthesis devices

All Mesh, surgical, acetabular, hip, prosthesis devices →

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