MAUDE Adverse Event Report: BIOMET MICROFIXATION FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE); SCREW, BONE 1.65 X 5 MM HIGH TORQUE SELF-DRILLING CROSS-DRIVE SCREW

Model Number N/A

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Infiltration into Tissue (1931); No Code Available (3191)

Event Date 07/28/2017

Event Type  Injury  

Manufacturer Narrative

The lot number is unknown; therefore the device history records are unable to be reviewed.The product remains implanted in the patient at this time, therefore no product evaluation can be performed.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.This is report eleven of eleven for the same event; reports one through ten are reported on mfr #0001032347-2017-00614 to 0001032347-2017-00623.

Event Description

The device was implanted on (b)(6) 2015.It is reported a revision will take place to remove the implants due to the device protruding through the patient's tissue.The anticipated revision date is unknown.More information was requested but has not been received at this time.

Manufacturer Narrative

This is supplemental report eleven of eleven for the same event; reference reports 0001032347-2017-00614-1 through 0001032347-2017-00623-1.

Event Description

Additional information was received, it is reported the patient's issue had nothing to do with the implant.The patient¿s body rejected the implant for unknown reasons, causing soft tissue break down on the left side of the mandible.The physician removed the mandible implant on (b)(6) 2017 and disposed of it.

• Brand Name: FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE)
• Type of Device: SCREW, BONE 1.65 X 5 MM HIGH TORQUE SELF-DRILLING CROSS-DRIVE SCREW
• 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: 6765221
• MDR Text Key: 81785030
• Report Number: 0001032347-2017-00624
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2017
• 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: 91-6105X
• 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: 09/29/2017
• 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: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention