MAUDE Adverse Event Report: NEOORTHO PRODUTOS ORTOPÉDICOS S/A NEOFIX; 900.353 - 12-HOLE BROAD 4.5 LS PLATE

Model Number 900.353

Device Problems Fracture (1260); Improper or Incorrect Procedure or Method (2017)

Patient Problem Non-union Bone Fracture (2369)

Event Date 08/05/2017

Event Type  Injury  

Manufacturer Narrative

It can be concluded that the product has gone through all stages of production and inspection and that the results of inspections and tests demonstrate that the product is in accordance with the safety and effectiveness of the project.Also, it is possible to verify that during the use of the product, the plate used maintained the bone alignment, but we observed a gap between the bone fragments evidencing the lack of compression as well as support between the fragments.This situation during the 4 months of implantation led to the implant fatigue.It is evident in the x-ray with the broken plate the total absence of bone callus and also that the plate have no deformation.This makes it clear that implant failure was due to fatigue caused by the lack of support between the fragments, which led to implant overload, absence of bone healing and fatigue rupture.Thus, plate rupture was due to the lack of reduction and support between the fragments, which led to the non-consolidation and overload of the implant.The unsuitable method of implant application had or contributed to a failure.

Event Description

Plate breakage 900.353, lot 3653795, about 4 months after its implantation.Patient: (b)(6) - with femur diaphysis fracture, operated on (b)(6) 2017 and progress to plate breakage.Plate replacement surgery on (b)(6) 2017.Other devices used: 903,110 lot 3642537, 903.110 lot:3622405, 903.112 lot:3646846, 901.135 lot:3637452, 901.136 lot:3655115, 901.137 lot: 3646905, 901.132 lot: 3647568, 901.134 lot: 3678916.

• Brand Name: NEOFIX
• Type of Device: 900.353 - 12-HOLE BROAD 4.5 LS PLATE
• Manufacturer (Section D): NEOORTHO PRODUTOS ORTOPÉDICOS S/A; r. angelo domingos durigan 605; curitiba, parana 82025 100; BR 82025100
• Manufacturer (Section G): NEOORTHO PRODUTOS ORTOPEDICOS S/A; angelo domingos durigan, 607; curitiba, parana 82025 100; BR 82025100
• Manufacturer Contact: mariana quinzani ; angelo domingos durigan, 607; curitiba, parana 82025-100 ; BR 82025100
• MDR Report Key: 6968769
• MDR Text Key: 89958598
• Report Number: 3009158523-2017-00003
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07898624861465
• UDI-Public: 07898624861465
• 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: Other
• Type of Report: Initial
• Report Date: 10/19/2017

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: 900.353
• Device Catalogue Number: 900.353
• Device Lot Number: 3653795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/20/2017
• Initial Date FDA Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2015
• 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: 78 YR
• Patient Weight: 69