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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC CONDYLE KIT W/ HEXALOBULA

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ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC CONDYLE KIT W/ HEXALOBULA Back to Search Results
Catalog Number 540-00-000
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/22/2019
Event Type  Injury  
Manufacturer Narrative
The reason for this revision surgery was due to condyle kit needed to be replaced. The date of the original surgery is unknown. The healthcare professional indicated there was no significant adverse event to the patient. There was no delay in surgery and another suitable device was available for use. The revision surgery was completed as intended. The device was disposed of at the hospital and not made available to djo surgical for examination. The part and or lot number of the device involved in this event was not provided. To adequately investigate this event, the part and or lot numbers are necessary. If this information is submitted at a future date, this investigation will be re-evaluated. No other information was submitted regarding the patient. The surgeon performed this revision to remedy the patient's condition. This complaint will be closed pending receipt of additional information. No further action is deemed necessary at this time.
 
Event Description
Revision surgery - due to condyle kit needed to be replaced.
 
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Brand NameDISCOVERY ELBOW
Type of DeviceDISC CONDYLE KIT W/ HEXALOBULA
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
teffany hutto
9800 metric blvd
austin, TX 78758-5445
MDR Report Key9204898
MDR Text Key162809970
Report Number1644408-2019-01067
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 Non-Healthcare Professional
Type of Report Initial
Report Date 10/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number540-00-000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/22/2019
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: 10/17/2019 Patient Sequence Number: 1
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