MAUDE Adverse Event Report: BIOMEDICAL ENTERPRISES, INC. TRIAD; STAPLE, FIXATION, BONE

Model Number	SE-201508TRL
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/12/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by distributor representative that x-ray performed on (b)(6) 2015 revealed implant was "backing out" of bone following a dorsal technique insertion ten weeks prior.Patient had returned for follow up due to pain and visible swelling.Revision surgery to remove implant is planned.

• Brand Name: TRIAD
• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): BIOMEDICAL ENTERPRISES, INC.; 14785 omicron dr., suite 205; san antonio TX 78245
• MDR Report Key: 5383958
• Report Number: 1649263-2016-00001
• Device Sequence Number: 298484
• Product Code: JDR
• UDI-Device Identifier: 00810633021620
• UDI-Public: 00810633021620
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K133844
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Report Date (Section B): 01/19/2016

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: No Information
• Device Expiration Date: 08/01/2020
• Device Model Number: SE-201508TRL
• Device Lot Number: BMESE155179
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Weight: 68