MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM CROSS-DRIVE FOSSA SCREW, 2.0 X 7 MM; BONE SCREW

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Hearing Loss (1882); Nerve Damage (1979)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product: biomet microfixation "2.4 mm" system high torque (ht) cross-drive screw 2.7 x 10 mm, catalog #: 91-2710, lot #: ni; biomet microfixation "2.7mm" system emergency cross drive screw, catalog #: 99-9950, lot #: ni; biomet microfixation tmj system left fossa component, small, catalog #: 24-6563, lot #: 761330b; biomet microfixation tmj system left narrow mandibular component, catalog #: 01-6546, lot #: 739700a.Therapy date: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, it remains implanted.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: 0001032347-2018-00670, 0001032347-2018-00672, 0001032347-2018-00673, and 0001032347-2018-00674.

Event Description

It was reported by the patient he has "hearing loss in the left ear, loss of feeling on the left side of his face, pain on the left side and inside the joint the fossa is rubbing." he stated that he last saw his surgeon in april at which time the surgeon indicated that there was no issue with the implants and with regard to the pain, numbness, and hearing loss, there is nothing more that can be done.The patient stated "you can't fix nerve damage".The patient confirmed that the parts remain implanted, there is no plan for revision, and no additional medical intervention.No additional patient consequences were reported.

Event Description

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

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.No product was returned, therefore no functional tests or inspections could be performed.No x-rays, scans, pictures, or physician's reports were provided.The complaint is non-verifiable.Device history record (dhr) was 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.The instructions for use (ifu) for this product warns of the potential for complications.It states in the section titled adverse events: loosening or displacement with or without removal of the implant.Facial swelling and/or pain.Facial nerve dysfunction.Ear problems.It also states in the section titled patient counseling information: discussion of the following points is recommended prior to surgery.The risks associated with a total tmj system (see warnings and adverse events).Post-operative pain relief and return of function varies from patient to patient.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 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: 0001032347-2018-00670-1, 0001032347-2018-00672-1, 0001032347-2018-00673-1, and 0001032347-2018-00674-1.

• Brand Name: TMJ SYSTEM CROSS-DRIVE FOSSA SCREW, 2.0 X 7 MM
• Type of Device: BONE SCREW
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 7935610
• MDR Text Key: 122801864
• Report Number: 0001032347-2018-00671
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• 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: 02/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability