MAUDE Adverse Event Report: BIOMET MICROFIXATION 45MM LEFT STANDARD MANDIBLE

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616)

Patient Problem Failure of Implant (1924)

Event Date 01/13/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Review of the device history records show that the lot was released with no recorded anomaly or deviation.The warnings in the package insert state this type of event can occur.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 3 of 7 for the same event.Reports 1 & 2, and 4 through 7 are reported on mfr #0001032347-2016-00235 through 0001032347-2016-00236 and 0001032347-2016-00238 through 0001032347-2016-00241.

Event Description

It was reported that a bilateral revision occurred as a result of the implants dislocating.

Manufacturer Narrative

It was identified on july 21, 2016 due to an inadvertent error, the device information submitted in this report was a duplicate of the device information in report 0001032347-2016-00235.Corrected from small left fossa component to 45mm left standard mandible.Corrected from fossa implant to mandible.Catalog number was corrected from 24-6563 to 24-6545.Lot number was corrected from 509610b to 509410b.Expiration date was corrected from 12/31/2018 to 5/1/2019.Unique identifier (udi) # was corrected from (b)(4).Device manufacture date was corrected from 1/1/2014 to 2/14/2014.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2016-00235-1, 0001032347-2016-00236-1, 0001032347-2016-00238-1, 0001032347-2016-00239-1, 0001032347-2016-00240-1, and 0001032347-2016-00241-1.

Event Description

Additional information was received.The patient that the joints were placed incorrectly during surgery on one side, beyond the socket area.The revised tmj implants were replaced with custom joints.

• Brand Name: 45MM LEFT STANDARD MANDIBLE
• Type of Device: MANDIBLE
• 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: 5676997
• MDR Text Key: 45852352
• Report Number: 0001032347-2016-00237
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP020016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2019
• Device Model Number: N/A
• Device Catalogue Number: 24-6545
• Device Lot Number: 509410B
• Other Device ID Number: SEE H10 NARRATIVE.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2016
• Initial Date FDA Received: 05/24/2016
• Supplement Dates Manufacturer Received: Not provided; 08/27/2018
• Supplement Dates FDA Received: 07/25/2016; 09/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention