MAUDE Adverse Event Report: BIOMEDICAL ENTERPRISES, INC. SPEED; SE-0907

Model Number	SE-0907
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/27/2013
Type of Reportable Event	Malfunction
Event or Problem Description
In (b)(6) 2013, two speed implants (se-0907) were inserted.During two week post operative visit, patient complained of pain and x-ray revealed that implants were backing out of bone.Revision surgery took place in (b)(6) 2013 and both implants were removed, using another unknown device for final fixation.If additional information pertinent to this incident is obtained, a supplemental report will be submitted.

• Brand Name: SPEED
• Common Device Name: SE-0907
• Manufacturer (Section D): BIOMEDICAL ENTERPRISES, INC.; 14785 omicron dr., suite 205; san antonio TX 78245
• MDR Report Key: 5868264
• Report Number: 1649263-2016-00038
• Device Sequence Number: 18925055
• Product Code: JDR
• UDI-Device Identifier: 00810633020197
• UDI-Public: 00810633020197
• Combination Product (Y/N): N
• PMA/510(K) Number: K102107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/10/2016

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: 08/01/2018
• Device Model Number: SE-0907
• Device Lot Number: BMESE135051B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2013
• Initial Report FDA Received Date: 08/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1