MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM CROSS DRIVE FOSSA SCREW; PLATE, BONE

Model Number N/A

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

Patient Problems Necrosis (1971); Nerve Damage (1979); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint: (b)(4).The device will not be returned to zimmer biomet for investigation because it remains implanted.The investigation is in process.Once the investigation is completed, a follow-up mdr report will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00371, 0001032347-2019-00372, 0001032347-2019-00373, 0001032347-2019-00374; 0001032347-2019-00375, 0001032347-2019-00376.Concomitant medical products: tmj system right narrow mandibular component, cat# 01-6545, lot# 710730a; tmj system left narrow mandibular component, cat# 01-6546, lot# 541380d; tmj system right fossa component small, cat# 24-6562, lot# 721350a; tmj system left fossa component small, cat# 24-6563, lot# 721500a; "2.4mm" system high torque (ht) cross-drive screw, cat# 91-2708, lot# unk; "2.4mm" system high torque (ht) cross-drive screw, cat# 91-2710, lot# unk; tmj system cross drive fossa screw, cat# 99-6579, lot# unk.

Event Description

It was reported that the patient underwent surgery to reposition temporomandibular implants due to necrosis and being too close to the ear canal.Implants remain implanted.The patient experienced numbness on the right bottom of their jaw and loss of facial expression that has not resolved following the repositioning of the implants.No additional patient consequences were reported.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint was opened because taylor billard, tmj tracking coordinator reports revision due to necrosis.Because a revision surgery occurred, the complaint is confirmed.No product was returned, therefore no functional tests or inspections could be performed.No x-rays, scans, pictures, or physician's reports were provided.It was reported that "the surgeon had to redo her right side due to necrosis and that it was the surgeon's fault and not our fault." there was no alleged malfunction of the devices.The dhr's for the screws in this case could not be reviewed due to the part number being unknown.There are no indications of manufacturing defects.The complaints histories for the screws involved in this case were not reviewed due to the lot numbers being unknown.The most likely underlying cause could not be determined from the information provided.It is possible that there was a patient condition that led to the issue.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.

• Brand Name: TMJ SYSTEM CROSS DRIVE FOSSA SCREW
• Type of Device: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8867867
• MDR Text Key: 153529946
• Report Number: 0001032347-2019-00377
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00841036057459
• UDI-Public: 00841036057459
• Combination Product (y/n): N
• PMA/PMN Number: K910038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• 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: 99-6579
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention