MAUDE Adverse Event Report: EXACTECH, INC. SMALL POSTERIOR AUGMENT GLENOID PLATE, LEFT; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number 320-35-03

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

Patient Problem Bone Fracture(s) (1870)

Event Date 12/22/2023

Event Type  Injury  

Manufacturer Narrative

(h3) pending evaluation.(d10) concomitant device(s): 320-36-03 - 145-deg pe 36mm hum liner +2.5: (b)(6).320-10-00 - equinoxe reverse tray adapter plate tray +0: (b)(6).320-15-05 - eq rev locking screw: (b)(6).320-20-00 - eq reverse torque defining screw kit: (b)(6).320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm: (b)(6).320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm: (b)(6).320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm: (b)(6).320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm: (b)(6).320-31-36 - glenosphere, 36mm: (b)(6).300-01-09 - equinoxe, humeral stem primary, press fit 9mm: (b)(6).

Event Description

As reported by the equinoxe shoulder study, the patient had an initial left tsa on (b)(6) 2021 and presented with scapular spine fracture (type 3), approximately 0 month(s) and 2 year(s) post-operatively on (b)(6) 2023.Displaced scapular spine fracture.The outcome of this event is considered continuing, with the action taken of other - considering orf.The case report form indicates that this event is possibly related to the device and unlikely related to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.

• Brand Name: SMALL POSTERIOR AUGMENT GLENOID PLATE, LEFT
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18811270
• MDR Text Key: 336592474
• Report Number: 1038671-2024-00350
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180632
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-35-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/22/2021
• 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