| Autor: |
Michael J. Radcliffe, DPM, Thomas S. Roukis, DPM, PhD, FACFAS |
| Jazyk: |
angličtina |
| Rok vydání: |
2024 |
| Předmět: |
|
| Zdroj: |
Foot & Ankle Surgery: Techniques, Reports & Cases, Vol 4, Iss 1, Pp 100344- (2024) |
| Druh dokumentu: |
article |
| ISSN: |
2667-3967 |
| DOI: |
10.1016/j.fastrc.2023.100344 |
| Popis: |
Background: The Lapiplasty® 3D Bunion Correction™ system represents an instrumented, jig-guided system to facilitate performing triplanar 1st tarsometatarsal joint arthrodesis. Literature available for this system is positive, although the vast majority is from inventor/consultant surgeons. The purpose of this manuscript is to review adverse event submissions recorded in the Manufacturer and User Facility Device Experience database specific to this system. Methods: The Manufacturer and User Facility Device Experience database was retrospectively reviewed from inception to 30 June 2023 for adverse events submitted for the Lapiplasty® 3D Bunion Correction™ system. Submissions that involved a medical device product other than this system, duplicate entries, and submissions with data extracted from already published literature were excluded. Results: A total of 180 unique reports that met inclusion criteria during the 5-year period available were reviewed. The mean time between event occurrence and submission was 46.7-days. The most common entity submitting to the database were the manufacturer company representative or distributor in 66.4%. The most frequently encountered patient problems were pain in 41.9%, non-union in 18.2%, and hardware-related irritation in 11.7%. Reports that detailed a revision surgery described partial/complete hardware removal in 62.7% and revision with additional hardware implantation in 23.3%. Conclusion: While no direct conclusions regarding the Lapiplasty® 3D Bunion Correction™ system can be drawn from the data as it consists of only adverse event reports, this study demonstrates the need for more non-inventor/consultant literature to further investigate adverse events related this particular system. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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