MAUDE Adverse Event Report: BIOMET MICROFIXATION UNKNOWN PRE-CONTOURED MESH; CRANIAL MESH

Model Number N/A

Device Problem Material Deformation (2976)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Because the part and lot numbers are unknown, the device history records could not be pulled and 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.

Event Description

The company representative reported that, "we are able to start with a few cases for precontoured meshes, we could see the shape great on day 1.After weeks time we see the change in the shape." it was reported that the product "used in( b)(6) had not held its curvature as well as expected by the customer.".

• Brand Name: UNKNOWN PRE-CONTOURED MESH
• Type of Device: CRANIAL MESH
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 6028423
• MDR Text Key: 57399005
• Report Number: 0001032347-2016-00578
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN PRE CONTOURED MESH
• 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: 09/15/2016
• 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): Other