MAUDE Adverse Event Report: BIOMEDICAL ENTERPRISES, INC. TITAN; SE-1818TI

Model Number	SE-1818TI
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/05/2015
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2015, patient underwent fixation procedure within the calcaneal cuboid joint, using a bme titan.At one week post operative, patient returned for follow up appointment and x-ray revealed that implant had broken.Device was removed on (b)(6) 2016.

• Brand Name: TITAN
• Common Device Name: SE-1818TI
• Manufacturer (Section D): BIOMEDICAL ENTERPRISES, INC.; 14785 omicron dr., suite 205; san antonio TX 78245
• MDR Report Key: 5545475
• Report Number: 1649263-2016-00007
• Device Sequence Number: 368838
• Product Code: JDR
• UDI-Device Identifier: 00810633021538
• UDI-Public: 00810633021538
• Combination Product (Y/N): N
• PMA/510(K) Number: K142292
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/03/2016

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 Expiration Date: 10/01/2019
• Device Model Number: SE-1818TI
• Device Lot Number: BMESE145145B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2016
• Initial Report FDA Received Date: 04/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 68