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

Model Number	SMALL POSTERIOR AUGMENT GLENOID PLATE, LEFT
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Periprosthetic fracture (4902)
Date of Event	10/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: 320-31-36 - glenosphere, 36mm 6934513; 320-36-00 - 36mm humeral liner +0 unconstrained 6960268; 300-01-13 - equinoxe, humeral stem primary, press fit 13mm; 320-10-00 - equinoxe reverse tray adapter plate tray +0.
Event or Problem Description
As reported, the patient had an initial left tsa on (b)(6) 2021.The patient presented with a coracoid fracture and the fracture was repaired.This event report was received through clinical data collection activities.
Additional Manufacturer Narrative
(h3) based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of coracoid fracture during surgery cannot be conclusively determined; however, it is most likely related to the surgical procedure.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b3, d8, e1, h6: clinical code, impact code, medical device problem code, component code, type of investigation, investigation findings.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: SMALL POSTERIOR AUGMENT GLENOID PLATE, LEFT
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15417265
• Report Number: 1038671-2022-01110
• Device Sequence Number: 6526203
• Product Code: PHX
• UDI-Device Identifier: 10885862534880
• UDI-Public: 10885862534880
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K180632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2025

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
• Operator of Device: Health Professional
• Device Model Number: SMALL POSTERIOR AUGMENT GLENOID PLATE, LEFT
• Device Catalogue Number: 320-35-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2022
• Supplement Date Received by Manufacturer: 09/22/2022; 10/31/2025
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 10/11/2022; 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White