MAUDE Adverse Event Report: BIOMET ORTHOPEDICS DVR EPAK NARROW LOCK PLATE R; PLATE, FIXATION

Model Number N/A

Device Problem Device Slipped (1584)

Patient Problem No Information (3190)

Event Date 04/28/2015

Event Type  Injury  

Event Description

It was reported patient underwent a fracture fixation procedure on an unknown date.During the procedure, the proximal screws pulled out of the radial shaft after an osteotomy.There has been no reported revision procedure to date.

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.The following sections could not be completed with the limited information provided.Catalog number, lot number and expiration date - unknown.Initial reporter phone : (b)(6).Manufacture date ¿ unknown.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, ¿loosening, migration, or fracture of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption and excessive activity.

Manufacturer Narrative

This follow-up report is being filed to relay additional information regarding product identification and procedure dates, which were unknown at the time of the initial medwatch.

Event Description

It was reported that the patient underwent a wrist osteotomy fixation procedure on (b)(6) 2014.Subsequently, a revision procedure was performed on (b)(6) 2015 due to the proximal screws backing out of the radial shaft.During the procedure, the fixation plate was removed and replaced.

• Brand Name: DVR EPAK NARROW LOCK PLATE R
• Type of Device: PLATE, FIXATION
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 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: 4531645
• MDR Text Key: 5538057
• Report Number: 0001825034-2015-00627
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PK112345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 811811050
• Device Lot Number: 199634
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2014
• 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