MAUDE Adverse Event Report: BIOMET TRAUMA DIST TIB ANTLAT LT NRW 6H STE; PLATE, FIXATION

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Staphylococcus Aureus (2058)

Event Date 06/08/2016

Event Type  Injury  

Manufacturer Narrative

There are warnings in the package insert that state this type of event can occur: under possible adverse effects, it states, ¿infection, both deep and superficial.¿ this report is number 15 of 18 mdrs filed for the same event (reference 1825034-2016-03272 / 3289).

Event Description

Patient underwent a procedure to remove locking plates and screws in both lower extremities approximately four months post implantation due signs of infection in the left lower extremity.Nothing was implanted to replace the products as the patient's bones had healed and the patient was treated with antibiotics.

• Brand Name: DIST TIB ANTLAT LT NRW 6H STE
• Type of Device: PLATE, FIXATION
• Manufacturer (Section D): BIOMET TRAUMA; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5906042
• MDR Text Key: 53076146
• Report Number: 0001825034-2016-03286
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK111663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 856203006
• Device Lot Number: DRBB0Z
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2016
• 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: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention