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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. RS GLENOID PLATE R POST AUG, 8 DEG, RIGHT; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
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EXACTECH, INC. RS GLENOID PLATE R POST AUG, 8 DEG, RIGHT; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED Back to Search Results
Catalog Number 320-15-04
Device Problem Naturally Worn (2988)
Patient Problem Failure of Implant (1924)
Event Date 11/08/2023
Event Type  Injury  
Event Description
It was reported that when impacting the glenoid plate the glenoid fractured.The surgeon decided to replace the glenoid plate with one with a longer cage to get better fixation.The sup/post augment provided better fixation.There was a 15-30 min delay.Patient was last known to be in stable condition following the event.
 
Manufacturer Narrative
Section h10: (h3) pending evaluation.
 
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Brand Name
RS GLENOID PLATE R POST AUG, 8 DEG, RIGHT
Type of Device
PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66 court
gainesville FL 32653
Manufacturer (Section G)
EXACTECH, INC.
2320 nw 66 ct
gainesville FL 32653
Manufacturer Contact
kate jacobson
2320 nw 66 ct
gainesville, FL 32653
3523771140
MDR Report Key18229606
MDR Text Key329268387
Report Number1038671-2023-02877
Device Sequence Number1
Product Code KWT
UDI-Device Identifier10885862186690
UDI-Public10885862186690
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110708
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 11/29/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number320-15-04
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/09/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/18/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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