MAUDE Adverse Event Report: BIOMET SPINE - BROOMFIELD MAXAN GREEN 1 LEVEL 8MM FIXED PLATE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Report two of two for the same event, reference 3004485144-2015-00046.

Event Description

On (b)(6) 2015 it was reported the patient had a revision to remove the plate and screws.The sales associate reported he believes the revision surgery was performed (b)(6) 2015 but was unable to confirm this date.

• Brand Name: MAXAN GREEN 1 LEVEL 8MM FIXED PLATE
• Type of Device: FIXED PLATE
• Manufacturer (Section D): BIOMET SPINE - BROOMFIELD; 310 interlocken parkway; suite 120; broomfield CO 80021
• Manufacturer (Section G): BIOMET SPINE - BROOMFIELD; 310 interlocken parkway; suite 120; broomfield CO 80021
• Manufacturer Contact: michelle cole ; 310 interlocken parkway; suite 120; broomfield, CO 80021 ; 3034437500
• MDR Report Key: 5136885
• MDR Text Key: 27825309
• Report Number: 3004485144-2015-00060
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK133518
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Report Date: 09/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 14-522108
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 39 YR