MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM CROSS DRIVE FOSSA SCREW 2.0X7MM; BONE SCREW

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Joint Dislocation (2374)

Event Date 04/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product: biomet microfixation tmj system right fossa component, medium catalog #: 24-6560 lot #: 793710d.Therapy date: (b)(6) 2018.Customer has indicated that the product will not be returned to zimmer biomet for investigation, it was retained by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2018-00525.

Event Description

It was reported there was a revision due to early post-op spontaneous dislocation and malocclusion.No additional patient consequences were reported.

Event Description

This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

There was a revision in which these parts were removed and replaced; therefore, the complaint is confirmed.Functional testing and inspections could not be performed due to the product not being returned and no photographs, x-rays, scans, or physician's reports being provided.For these reasons, the most likely underlying cause cannot be determined.The instructions for use (ifu) for this product has the following information in the section titled adverse events: removal of components(s) including, but not limited to the following: implant changes caused by loading and/or wear.Degenerative changes within the joint surfaces from disease or previous implants.Implant materials producing particles or corroding.Loosening or displacement with or without removal of the implant.Dislocation.Device history record (dhr) for the fossa component was reviewed and no discrepancies were found.Dhr review was unable to be performed for the screws as the lot number of the devices involved in the event are unknown.There are no indications of manufacturing defects.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2018-00525-1.

• Brand Name: TMJ SYSTEM CROSS DRIVE FOSSA SCREW 2.0X7MM
• Type of Device: BONE SCREW
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 7748163
• MDR Text Key: 115971760
• Report Number: 0001032347-2018-00524
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• PMA/PMN Number: PK910038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 99-6577
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention