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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL LP DISCOVERY ELBOW DISC CONDYLE KIT W/ HEXALOBULA

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ENCORE MEDICAL LP DISCOVERY ELBOW DISC CONDYLE KIT W/ HEXALOBULA Back to Search Results
Model Number 540-00-000
Device Problems Fracture (1260); Appropriate Term/Code Not Available (3191)
Patient Problem Failure of Implant (1924)
Event Date 07/19/2021
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
Revision surgery - patient fractured above the humeral component. Removed and put in an srs system.
 
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Brand NameDISCOVERY ELBOW
Type of DeviceDISC CONDYLE KIT W/ HEXALOBULA
Manufacturer (Section D)
ENCORE MEDICAL LP
9800 metric blvd
austin TX 78758 5445
Manufacturer (Section G)
ENCORE MEDICAL LP
9800 metric blvd
austin TX 78758 5445
Manufacturer Contact
kiersten soderman
9800 metric blvd
austin, TX 78758-5445
MDR Report Key12249856
MDR Text Key264257449
Report Number1644408-2021-00776
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051975
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number540-00-000
Device Catalogue Number540-00-000
Device Lot Number70587
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/04/2021
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: 07/29/2021 Patient Sequence Number: 1
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