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 Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: biomet microfixation tmj system right standard mandibular component 45 mm, catalog #: 24-6545, lot #: 535300a; biomet microfixation tmj system right fossa component, small, catalog #: 24-6562, lot #: 532760b; biomet microfixation tmj system left standard mandibular component 45 mm, catalog #: 24-6546, lot #: 537500c; biomet microfixation tmj system left fossa component, small, catalog #: 24-6563, lot #: 539220b; biomet microfixation 2.4 mm system high torque (ht) cross-drive screw, catalog #: 91-2708, lot #: ni; biomet microfixation tmj system cross drive fossa screw, catalog #: 99-6577, lot #: ni; biomet microfixation 2.7 mm system emergency cross drive screw, catalog #: 99-9948, lot #: ni.Concomitant medical products therapy date: ni.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted in the patient.Reported event was unable to be confirmed due to limited information received from the customer.Product identity confirmed via tmj tracking.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.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.The instructions for use (ifu) for this product has adverse events that may occur following placement of the total tmj replacement system in the section titled adverse events: facial swelling and/or pain; loosening or displacement with or without removal of the implant; dislocation.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.There are no indications of manufacturing defects.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: 0001032347-2019-00068 through 0001032347-2019-00075.

Event Description

It was reported by the patient that she is receiving treatment for her headaches in the mandibular area.The patient also reported experiencing mandibular pain, tooth pain, and spitting blood.Attempts have been made and no further information has been provided.No additional patient consequences were reported.

• 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
• 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: 8295388
• MDR Text Key: 134698371
• Report Number: 0001032347-2019-00074
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2019
• 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
• Date Manufacturer Received: 01/17/2019
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention