MAUDE Adverse Event Report: BIOMEDICAL ENTERPRISES, INC. TRIAD; SE-181508TRC

Model Number	SE-181508TRC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/15/2015
Type of Reportable Event	Malfunction
Event or Problem Description
One triad implant (se-181508trc) was inserted on unknown date.On (b)(6) 2015, broken implant was removed, it was returned to manufacturer on unknown date.If additional information pertinent to this incident is obtained, a supplemental report will be submitted.

• Brand Name: TRIAD
• Common Device Name: SE-181508TRC
• Manufacturer (Section D): BIOMEDICAL ENTERPRISES, INC.; 14785 omicron dr., suite 205; san antonio TX 78245
• MDR Report Key: 5694923
• Report Number: 1649263-2016-00032
• Device Sequence Number: 103725
• Product Code: JDR
• UDI-Device Identifier: 00810633021613
• UDI-Public: 00810633021613
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K133844
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/31/2016

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 Number: SE-181508TRC
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/02/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1