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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. DISCOVERY ELBOW; DISC HUM 5X100MM RT FLANGED C
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ENCORE MEDICAL, L.P. DISCOVERY ELBOW; DISC HUM 5X100MM RT FLANGED C Back to Search Results
Catalog Number 114907
Device Problems Fracture (1260); Loose or Intermittent Connection (1371)
Patient Problem Fall (1848)
Event Date 10/07/2016
Event Type  Injury  
Event Description
Revision surgery due to the patient falling and fracturing his right arm, where he had previously had surgery to implant the discovery elbow.After the fracture healed the humeral was found to be loose.
 
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Brand Name
DISCOVERY ELBOW
Type of Device
DISC HUM 5X100MM RT FLANGED C
Manufacturer (Section D)
ENCORE MEDICAL, L.P.
9800 metric blvd.
austin TX 78758
Manufacturer (Section G)
ENCORE MEDICAL, L.P.
9800 metric blvd.
austin TX 78758
Manufacturer Contact
teffany hutto
9800 metric blvd.
austin, TX 78758-5445
5128346255
MDR Report Key6077632
MDR Text Key59116476
Report Number1644408-2016-00825
Device Sequence Number1
Product Code JDC
UDI-Device Identifier00888912225496
UDI-Public(01)00888912225496
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 Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 10/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number114907
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/07/2016
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 Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age77 YR
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