MAUDE Adverse Event Report: BIOMEDICAL ENTERPRISES, INC. SPEED; SE-131513

Model Number	SE-131513
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/01/2013
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
One speed was inserted appropriately during med cuneiform/navicular fusion procedure dos unknown.Follow-up x-ray (b)(6) 2013 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-131513
• Manufacturer (Section D): BIOMEDICAL ENTERPRISES, INC.; 14785 omicron dr., suite 205; san antonio TX 78245
• MDR Report Key: 5548838
• Report Number: 1649263-2016-00018
• Device Sequence Number: 347539
• Product Code: JDR
• UDI-Device Identifier: 00810633020234
• UDI-Public: 00810633020234
• Combination Product (Y/N): N
• PMA/510(K) Number: K142292
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/15/2016

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: 03/01/2017
• Device Model Number: SE-131513
• Device Lot Number: BMESE121313
• Was Device Available for Evaluation?: No
• Device Age: 3 YR
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2013
• 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: 45 YR
• Patient Weight: 68