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

Model Number SE-1818TI

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 02/05/2015

Event Type  malfunction  

Event 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
• Type of Device: SE-1818TI
• Manufacturer (Section D): BIOMEDICAL ENTERPRISES, INC.; 14785 omicron dr., suite 205; san antonio TX 78245
• Manufacturer Contact: joe soward ; 14785 omicron dr., suite 205; san antonio, TX 78245 ; 2108810011
• MDR Report Key: 5545475
• MDR Text Key: 41820877
• Report Number: 1649263-2016-00007
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00810633021538
• UDI-Public: 00810633021538
• Combination Product (y/n): N
• PMA/PMN Number: K142292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Physician
• Device Expiration Date: 10/01/2019
• Device Model Number: SE-1818TI
• Device Lot Number: BMESE145145B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/05/2016
• Initial Date FDA Received: 04/04/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/14/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 68