MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM CROSS DRIVE EMERGENCY FOSSA SCREW, 2.3 X 7 MM; SCREW, BONE

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Unspecified Infection (1930); Joint Dislocation (2374)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: (b)(6) 2018.(b)(4).Explant date: (b)(6) 2018.Concomitant medical devices: biomet microfixation tmtmj system right fossa component small, catalog #: 24-6562, lot #: 718390g; biomet microfixation tmj system right narrow mandibular component, catalog #: 01-6545, lot #: 723550a; biomet microfixation tmj system cross drive fossa screw, catalog #: 99-6577; biomet microfixation 2.4mm system 2.7mm x 10mm ht cross-drive screw, 5/pk, catalog #: 85-2710.Therapy date: (b)(6) 2018.Foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, they surgeon wishes to keep it.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: 0001032347-2018-00772 through 0001032347-2018-00776.

Event Description

It was reported a revision was performed due to an infection that resulted from a trauma to the lower jaw that displaced the implant.The lower jaw was misaligned and caused impinging of the ear canal and damage to the fossa bone area.A custom implant was requested for future implantation.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 to remove these implants; therefore the complaint is considered confirmed.Functional testing and inspections could not be performed due to the parts not being returned and no photographs, x-rays, scans, or physician reports being provided.Based on the information and materials provided, there does not appear to be an allegation made against the implants to function as intended.It is possible that the trauma reported caused displacement of the implants and subsequent infection if there were open wounds or fractures.Device history records (dhrs) were reviewed for the tmj components and no discrepancies were found.Dhr review was unable to be performed for the screws as the lot numbers of the devices involved in the event are unknown.There are no indications of manufacturing defects.Investigation results concluded that the reported event was due to patient impact/activity.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2018-00772-1, 0001032347-2018-00773-1, 0001032347-2018-00774-1, and 0001032347-2018-00776-1.

• Brand Name: TMJ SYSTEM CROSS DRIVE EMERGENCY FOSSA SCREW, 2.3 X 7 MM
• Type of Device: SCREW, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8070768
• MDR Text Key: 127137855
• Report Number: 0001032347-2018-00775
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• PMA/PMN Number: K910038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 03/19/2019

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 Model Number: N/A
• Device Catalogue Number: 99-6587
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/15/2018
• Initial Date FDA Received: 11/14/2018
• Supplement Dates Manufacturer Received: 02/22/2019
• Supplement Dates FDA Received: 03/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention