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

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	03/16/2016
Type of Reportable Event	Malfunction
Event or Problem Description
Two speed implants (se-1818, se-1515) were inserted appropriately during lis franc procedure (b)(6) 2015.On or around (b)(6) 2016, broken implants were removed.If additional information pertinent to this incident is obtained, a supplemental report will be submitted.

• Brand Name: SPEED
• Common Device Name: SE-1818
• Manufacturer (Section D): BIOMEDICAL ENTERPRISES, INC.; 14785 omicron dr., suite 205; san antonio TX 78245
• MDR Report Key: 5609512
• Report Number: 1649263-2016-00029
• Device Sequence Number: 973356
• 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
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/15/2016

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: 07/01/2020
• Device Model Number: SE-1818
• Device Lot Number: BMESE155170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2016
• Initial Report FDA Received Date: 04/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Weight: 136