MAUDE Adverse Event Report: EXACTECH, INC. GLENOSPHERE LOCKING SCREW

Catalog Number 9999

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Irritation (1941); No Code Available (3191)

Event Date 06/21/2017

Event Type  Injury  

Manufacturer Narrative

This event report was received through clinical data collection activities.Pending evaluation.

Event Description

Index surgery: (b)(6) 2015.Revision due to suprascapular nerve irritation from screw.The case report form indicates this event is possibly related to devices and definitely related to procedure.

Manufacturer Narrative

Engineering evaluation noted that the revision reported was likely the result of nerve irritation due to the positioning and/or length of one of the compression screws used to secure the glenoid plate.

Manufacturer Narrative

Engineering evaluation noted that the revision reported was likely the result of nerve irritation due to the positioning and/or length of one of the compression screws used to secure the glenoid plate.

• Brand Name: GLENOSPHERE LOCKING SCREW
• Type of Device: GLENOSPHERE LOCKING SCREW
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 8085817
• MDR Text Key: 127618067
• Report Number: 1038671-2018-00888
• Device Sequence Number: 0
• Product Code: KWT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9999
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 68