MAUDE Adverse Event Report: EXACTECH, INC. SMALL EXTENDED CAGE GLENOID PLATE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-35-06
Medical Device Problem Codes	Break (1069); Material Deformation (2976); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the implant was opened and loaded with bone graft by the surgical tech before impaction.During impaction the implant would not fully seat and was pulled out to reassess.Upon loading the implant back on the inserter it was noticed by the tech that the cage had warped.The surgeon then decided to waste the implant and put in a new one.The new baseplate was impacted with no issues.This event is not associated with a revision of exactech implants.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: a, b, c, d, f, g.The incomplete seating and deformation reported may have been the result of improper bone preparation secondary to insufficient drilling for the depth of the cage or off-axis drilling of the holes for the glenoid, leading to deformation of the cage.However, this cannot be confirmed because the component was not returned for evaluation.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: SMALL EXTENDED CAGE GLENOID PLATE
• Common Device Name: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19177879
• Report Number: 1038671-2024-00971
• Device Sequence Number: 12509763
• Product Code: KWT
• UDI-Device Identifier: 10885862534903
• UDI-Public: 10885862534903
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K180632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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 Catalogue Number: 320-35-06
• 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: 04/01/2024
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/31/2019
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female