MAUDE Adverse Event Report: TORNIER SAS AEQUALIS REVERSED GLENOID BASEPLATE

Catalog Number DWD170

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 05/02/2015

Event Type  Injury  

Manufacturer Narrative

This is the initial report submitted regarding this surgical event and medical device.

Event Description

After 2 weeks from the initial surgery, baseplate with sphere and screws dropped off form glenoid.Revision surgery done on (b)(6) 2015.

• Brand Name: AEQUALIS REVERSED GLENOID BASEPLATE
• Type of Device: AEQUALIS REVERSED GLENOID BASEPLATE
• Manufacturer (Section D): TORNIER SAS; montbonnot, ; FR
• Manufacturer Contact: segolene pollet ; FR
• MDR Report Key: 5815085
• MDR Text Key: 176483566
• Report Number: 3000931034-2015-00108
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131231
• 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: 05/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: DWD170
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/02/2015
• Initial Date FDA Received: 07/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• 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): Other