MAUDE Adverse Event Report: BIOMEDICAL ENTERPRISES, INC. SPEED; SE-2020TI

Model Number	SE-1818
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/22/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation, should the device be returned or additional information become available, a supplemental report will be submitted.
Event or Problem Description
Speed (se-1818) was inserted appropriately during tn fusion procedure (b)(6) 2015.Follow-up x-ray (b)(6) 2015 revealed that implant had broken.Patient has not required revision surgery, nor removal of broken implant.If additional information pertinent to this incident is obtained, a supplemental report will be submitted.

• Brand Name: SPEED
• Common Device Name: SE-2020TI
• Manufacturer (Section D): BIOMEDICAL ENTERPRISES, INC.; 14785 omicron dr., suite 205; san antonio TX 78245
• MDR Report Key: 5548362
• Report Number: 1649263-2016-00011
• Device Sequence Number: 349581
• Product Code: JDR
• UDI-Device Identifier: 00810633020197
• UDI-Public: 00810633020197
• Combination Product (Y/N): N
• PMA/510(K) Number: K142292
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/14/2016

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: 01/01/2019
• Device Model Number: SE-1818
• Device Lot Number: BMESE135074B
• Was Device Available for Evaluation?: No
• Device Age: 2 YR
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2015
• Initial Report FDA Received Date: 04/05/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 79