MAUDE Adverse Event Report: BIOMET SPINE LATERAL INTERVERTEBRAL BODY/VBR FUSION SYSTEM; LATERAL ARTICULATING ARM

Model Number 8734-0020

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/06/2015

Event Type  malfunction  

Event Description

During surgery, the arm joint in the articulating arm was unable to be tightened.Even though the incision was made and the retractor was inserted into the patient, the surgery was cancelled and the wound was closed without completing the procedure.

• Brand Name: LATERAL INTERVERTEBRAL BODY/VBR FUSION SYSTEM
• Type of Device: LATERAL ARTICULATING ARM
• Manufacturer (Section D): BIOMET SPINE; broomfield CO
• Manufacturer Contact: stephen morey ; 310 interlocken parkway; suite 120; broomfield, CO 80021 ; 3034437500
• MDR Report Key: 4564319
• MDR Text Key: 18922160
• Report Number: 3004485144-2015-00003
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8734-0020
• Device Lot Number: L555566
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/10/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other