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HammerLock HLXMARecalls & reported problems

Biomedical Enterprises, Inc. · Hammerlock Angled X-Type Medium 19 · 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 00810633020043), received between Aug 11, 2016 and Aug 11, 2016 — classified as 1 injury.

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

  • Break1

Patient problems

  • Unspecified Infection1

Recent adverse event reports

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

  • InjuryAug 11, 2016Break; Break

    ON (B)(6) 2011 HAMMERLOCK (HLXMA) WAS INSERTED DURING HAMMERTOE CORRECTION. IMPLANT WAS LATER REMOVED ON OR AROUND (B)(6) 2013 DUE TO INFECTION. DURING EXPLANTATION OR PRIOR, IMPLANT LEG WAS BROKEN AND ALL DEBRIS COULD NOT BE EXTRACTED. IT IS UNCONFIRMED WHETHER INFECTION WAS DUE TO IMPLANTED DEVICE. IF ADDITIONAL INFORMATION PERTINENT TO THIS INCIDENT IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Patient problems: Unspecified Infection

    MAUDE report 5868225 ↗

Other Pin, Fixation, Smooth devices

All Pin, Fixation, Smooth devices →

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