MAUDE Adverse Event Report: NEOORTHO PRODUTOS ORTOPEDICOS S/A NEOFIX; 900.313 8-HOLE 3.5 RECONSTRUCTION LS PLATE

Model Number 900.313

Device Problems Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889)

Patient Problem Bone Fracture(s) (1870)

Event Date 09/30/2018

Event Type  Injury  

Manufacturer Narrative

According to the medical report and report of the medical staff, we can say that the deformation of the implant occurred due to improper use of the material.In osteosynthesis of the humeral shaft, plates that perform the function of compression and / or blocking of large fragments should be used 4.5 mm screws, since the moldable small fragments reconstruction plate, which uses 3.5mm screws, is indicated for bone reconstruction.Analyzing the radiographic images made available by the client to investigate the case.We observed signs of non-consolidation and loss of bone contact between fragments and the use of a moldable plate did not offer mechanical support to the fractured bone, failing in the purpose of fracture stabilization.The product went through all stages of production and inspection, and the results of the inspections and tests show that the product met the safety and efficacy level of the project.The plate deformation occurred due to the inadequate use of the plate, with no indication that occured structural failure of the implant in the manufacture process or raw material.

Event Description

The plate was bended after implantation.

• Brand Name: NEOFIX
• Type of Device: 900.313 8-HOLE 3.5 RECONSTRUCTION LS PLATE
• Manufacturer (Section D): NEOORTHO PRODUTOS ORTOPEDICOS S/A; rua angelo domingos durigan; curitiba, parana 82025 100; BR 82025100
• Manufacturer (Section G): NEOORTHO PRODUTOS ORTOPEDICOS S/A; angelo domingos durigan; curitiba, parana 82025 100; BR 82025100
• Manufacturer Contact: mariana quinzani ; rua angelo domingos durigan; curitiba, parana 82025-100 ; BR 82025100
• MDR Report Key: 8025510
• MDR Text Key: 125746051
• Report Number: 3009158523-2018-00001
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07898624860673
• UDI-Public: 07898624860673
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K113733
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 900.313
• Device Catalogue Number: 900.313
• Device Lot Number: 3655310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2018
• Initial Date Manufacturer Received: 10/02/2018
• Initial Date FDA Received: 10/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR
• Patient Weight: 70