MAUDE Adverse Event Report: SYNTHES USA 2.4MM TI CORTEX SCREW SELF-TAPPING 6MM

Catalog Number 401.506

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Cellulitis (1768); Non-union Bone Fracture (2369)

Event Type  Injury  

Event Description

It was reported that a patient was originally treated with a fibula free flap reconstruction on the left side of the mandible.The patient presented in the emergency room with signs of cellulitis.Patient was placed on antibiotics and brought to the operating room.The surgeon removed five screws and one reconstruction plate and a non-union was observed.The surgeon debrided the mandible and soft tissue, and placed a mandible ex-fix.Surgery was successfully completed.This report is 3 of 6 for complaint (b)(4).

Manufacturer Narrative

Device is used for treatment, not diagnosis.Investigation could not be completed, no conclusion could be drawn as no device was returned and no lot number was provided.Manufacturing records could not be reviewed without a lot number.Placeholder.

• Brand Name: 2.4MM TI CORTEX SCREW SELF-TAPPING 6MM
• Manufacturer (Section D): SYNTHES USA; west chester PA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3643806
• MDR Text Key: 16686720
• Report Number: 2520274-2014-00798
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 401.506
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 78