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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P DISCOVERY ELBOW DISC ULNA 4X155MM LT W/BRNG C

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ENCORE MEDICAL L.P DISCOVERY ELBOW DISC ULNA 4X155MM LT W/BRNG C Back to Search Results
Catalog Number 114828
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Fracture, Arm (2351)
Event Date 02/03/2021
Event Type  Injury  
Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
 
Event Description
Second revision surgery - due to fractured ulna.
 
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Brand NameDISCOVERY ELBOW
Type of DeviceDISC ULNA 4X155MM LT W/BRNG C
Manufacturer (Section D)
ENCORE MEDICAL L.P
9800 metric blvd
austin,tx 78758-5445
Manufacturer (Section G)
ENCORE MEDICAL L.P
9800 metric blvd
austin,tx 78758-5445
Manufacturer Contact
kiersten soderman
9800 metric blvd
austin, TX 78758-5445
MDR Report Key11404563
MDR Text Key234438745
Report Number1644408-2021-00132
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K013042
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 04/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/17/2022
Device Catalogue Number114828
Device Lot Number543760
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/03/2021 Patient Sequence Number: 1
Treatment
114700 LOT 885790
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