MAUDE Adverse Event Report: TORNIER SAS AEQUALIS REVERSED II NON STERILE SCREW 38MM

Catalog Number DWD038

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

This is the initial report submitted regarding this surgical event and medical device.The information contained in this report is being provided to the fda to comply with regulations regarding medical device reporting and is based on information submitted by others that may or may not be factually correct.This submission does not constitute a determination or admission that a device has malfunction or is related to a death or injury.

Event Description

The dr explanted everything due to patient having pain and suspicion of infection.

• Brand Name: AEQUALIS REVERSED II NON STERILE SCREW 38MM
• Type of Device: AEQUALIS REVERSED II NON STERILE SCREW 38MM
• Manufacturer (Section D): TORNIER SAS; montbonnot, ; FR
• Manufacturer Contact: segolene pollet ; 161 rue lavoisier; montbonnot, cedex 38334 ; FR 38334
• MDR Report Key: 5815072
• MDR Text Key: 176048761
• Report Number: 3000931034-2015-00017
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/19/2015

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 Catalogue Number: DWD038
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/19/2015
• Initial Date FDA Received: 07/24/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2010
• 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: 76 YR