MAUDE Adverse Event Report: BIOMEDICAL ENTERPRISES, INC. SPEED; SE-1512

Model Number	SE-1512
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/01/2015
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-1512) was inserted appropriately during lapidus procedure (b)(6) 2014.Follow-up x-ray in (b)(6) 2015 revealed that implant had broken after patient reported tripping.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-1512
• Manufacturer (Section D): BIOMEDICAL ENTERPRISES, INC.; 14785 omicron dr., suite 205; san antonio TX 78245
• MDR Report Key: 5548797
• Report Number: 1649263-2016-00013
• Device Sequence Number: 726490
• Product Code: JDR
• UDI-Device Identifier: 00810633020166
• UDI-Public: 00810633020166
• Combination Product (Y/N): N
• PMA/510(K) Number: K142292
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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: 01/01/2018
• Device Model Number: SE-1512
• Device Lot Number: BME135026C
• Was Device Available for Evaluation?: No
• Device Age: 2 YR
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2015
• 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: 44 YR
• Patient Weight: 68