MAUDE Adverse Event Report: BIOMEDICAL ENTERPRISES, INC. SPEED; STAPLE, FIXATION, BONE

Model Number SE1515

Device Problem Fracture (1260)

Patient Problem Pain (1994)

Event Date 09/20/2015

Event Type  malfunction  

Manufacturer Narrative

Device not returned for evaluation.

Event Description

At 7 month post operative visit, x-ray revealed that speed implants sized 1515 and 1818 had broken.Patient underwent revision surgery in (b)(6) 2015.Broken implants were removed and claw plate was inserted during cc fusion procedure.

• Brand Name: SPEED
• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): BIOMEDICAL ENTERPRISES, INC.; 14785 omicron dr., 205; san antonio TX 78245
• Manufacturer Contact: joe soward ; 14785 omicron dr., suite 205; san antonio, TX 78245 ; 2108810011
• MDR Report Key: 5278759
• MDR Text Key: 33067895
• Report Number: 1649263-2015-00008
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/01/2019
• Device Model Number: SE1515
• Device Lot Number: BMESE135134B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 68