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MDR - Biomet Cannulated Screws

2019-07-05 07:10:35 | BioPortfolio

Summary

The objective of this retrospective enrollment/prospective follow up study is to collect data confirming safety, performance, and clinical benefits of the Biomet Cannulated Bone Screw System (Implants and Instrumentation) when used according to the approved Indications for Use (IFU).

Description

The objective of this retrospective enrollment/prospective follow up study is to collect data confirming safety, performance, and clinical benefits of the Biomet Cannulated Bone Screw System (Implants and Instrumentation) when used according to the approved Indications for Use (IFU).

Safety will be established by recording the incidence and frequency of complications and adverse events. Relationship of the events to either implant or instrumentation should be specified.

Performance and clinical benefits will be assessed by analyzing fracture healing/fusion and the overall pain and functional performance of subjects who received the Biomet Cannulated Bone Screws by recording survey questions. Zimmer Biomet defines the expected performance rate for Cannulated Screws for long and small bone fractures to be a union rate of at least 81% at 8-12 months.

Study Design

Conditions

Fractures, Bone

Intervention

Biomet Cannulated Screw: 3.0, 4.0, 5.0, 6.5, and 8.0mm screws.

Location

Zimmer Biomet
Warsaw
Indiana
United States
46580

Status

Not yet recruiting

Source

Zimmer Biomet

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-07-05T07:10:35-0400

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PubMed Articles [4630 Associated PubMed Articles listed on BioPortfolio]

Cannulated Screw Prominence in Tension Band Wiring of Patella Fractures Increases Fracture Gapping: A Cadaver Study.

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Medical and Biotech [MESH] Definitions

Specialized devices used in ORTHOPEDIC SURGERY to repair bone fractures.

BONE SCREWS to be used in the pedicle of the vertebral arch.

Fractures of the short, constricted portion of the thigh bone between the femur head and the trochanters. It excludes intertrochanteric fractures which are HIP FRACTURES.

Crumbling or smashing of cancellous BONE by forces acting parallel to the long axis of bone. It is applied particularly to vertebral body fractures (SPINAL FRACTURES). (Blauvelt and Nelson, A Manual of Orthopedic Terminology, 1994, p4)

Fractures due to the strain caused by repetitive exercise. They are thought to arise from a combination of MUSCLE FATIGUE and bone failure, and occur in situations where BONE REMODELING predominates over repair. The most common sites of stress fractures are the METATARSUS; FIBULA; TIBIA; and FEMORAL NECK.

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