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

Model Number SE-201508TRL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 01/12/2016

Event Type  malfunction  

Event 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
• Type of Device: STAPLE, FIXATION, BONE
• 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: 5383958
• MDR Text Key: 36566126
• Report Number: 1649263-2016-00001
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00810633021620
• UDI-Public: 00810633021620
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133844
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: No Information
• Device Expiration Date: 08/01/2020
• Device Model Number: SE-201508TRL
• Device Lot Number: BMESE155179
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/07/2016
• Initial Date FDA Received: 01/21/2016
• Date Device Manufactured: 08/12/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 68