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OsteoMed 317-4052Recalls & reported problems

Osteomed LLC · 4.0mm X 52mm Cannulated Headless Screw · Class 2

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 00845694027694), received between Mar 26, 2019 and Mar 26, 2019 — classified as 1 malfunction.

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

  • Appropriate Device Problem Term/Code Not Available1

Patient problems

  • Inadequate Pain Relief1

Recent adverse event reports

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

  • MalfunctionMar 26, 2019Appropriate Device Problem Term/Code Not Available

    ON (B)(6) 2019, OSTEOMED WAS NOTIFIED OF AN ADVERSE EVENT CONCERNING OUR 4.0MM X 52MM CANNULATED HEADLESS SCREW. WHILE REVIEWING INFORMATION OBTAINED FOR A COMPLAINT, IT WAS IDENTIFIED THAT ANOTHER SCREW IMPLANT WAS EXPLANTED IN 2017. THEREFORE, THIS COMPLAINT WAS INITIATED FOR THE EXPLANTED DEVICE. PER THE INFORMATION RECEIVED FROM THE DISTRIBUTOR, WITHIN THE OPERATIVE NOTES CONCERNING THE PATIENT ASSOCIATED WITH COMPLAINT (B)(4), THE ORIGINAL SURGERY WAS ON (B)(6) 2017. AT SOME POINT THE PATIENT COMPLAINED OF PAIN, AND ON (B)(6) 2017 THE IMPLANT WAS REMOVED. COMPLAINT (B)(4) WAS PREVIOUSLY REPORTED UNDER MDR# 2027754-2019-00005.

    Patient problems: Inadequate Pain Relief

    MAUDE report 8452479 ↗

Other Screw, fixation, bone devices

All Screw, fixation, bone devices →

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