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

Model Number SE-0907

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 09/27/2013

Event Type  malfunction  

Event 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
• Type of Device: SE-0907
• Manufacturer (Section D): BIOMEDICAL ENTERPRISES, INC.; 14785 omicron dr., suite 205; san antonio TX 78245
• Manufacturer Contact: joe soward ; 14785 omicron dr., suite 205; san antonio, TX 78245 ; 2108810011
• MDR Report Key: 5868275
• MDR Text Key: 51942805
• Report Number: 1649263-2016-00037
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00810633020197
• UDI-Public: 00810633020197
• Combination Product (y/n): N
• PMA/PMN Number: K102107
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Physician
• Device Expiration Date: 08/01/2018
• Device Model Number: SE-0907
• Device Lot Number: BMESE135051B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/27/2013
• Initial Date FDA Received: 08/11/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/03/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1