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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMEDICAL ENTERPRISES, INC. TITAN; SE-2015TI
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BIOMEDICAL ENTERPRISES, INC. TITAN; SE-2015TI Back to Search Results
Model Number SE-2015TI
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 10/16/2015
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation, should the device be returned or additional information become available, a supplemental report will be submitted.
 
Event or Problem Description
Speed titan ((b)(4)) was inserted appropriately during midfoot procedure (b)(6) 2015.Follow-up x-ray on (b)(6) 2015 revealed that implant had broken.Patient has not required revision surgery, nor removal of broken implant.If additional information pertinent to this incident is obtained, a supplemental report will be submitted.
 
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Brand Name
TITAN
Common Device Name
SE-2015TI
Manufacturer (Section D)
BIOMEDICAL ENTERPRISES, INC.
14785 omicron dr., suite 205
san antonio TX 78245
MDR Report Key5548834
Report Number1649263-2016-00008
Device Sequence Number973115
Product Code JDR
UDI-Device Identifier00810633021576
UDI-Public00810633021576
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
PMA/510(K) Number
K142292
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 03/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Physician
Device Model NumberSE-2015TI
Device Lot NumberBMESE145113B
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/16/2015
Initial Report FDA Received Date04/05/2016
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age67 YR
Patient Weight75
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