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

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Swelling (2091); Sleep Dysfunction (2517)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00236, 0001032347-2020-00237, 0001032347-2020-00238, 0001032347-2020-00239.Concomitant medical products: tmj system left narrow mandibular component 45 mm / 6 hole, part# 01-6546, lot# 862970c.Tmj system left fossa component, small, part# 24-6563, lot# 886860c.2.4mm system high torque (ht) cross-drive screw 2.7mm x 8mm, part# 91-2708, lot# ni.2.4mm system high torque (ht) cross-drive screw 2.7 x 10mm, part# 91-2710, lot# ni.Tmj system cross drive fossa screw 2.0mm x 7mm, part# 99-6577, lot# ni.Initial reporter occupation ¿ patient.

Event Description

It was reported that the patient attended oral therapy sessions and a potentially loose screw was discovered following implantation of temporomandibular implants on the left side eleven (11) months ago.The patient reports swelling on the left side of the mouth and face, and reports difficulty sleeping on the left side.The patient attended ten oral therapy sessions to reportedly break down scar tissue, and the therapist discovered a possibly loose screw.No additional patient consequences have been reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint is considered to be confirmed because the patient received additional treatment from the oral therapist.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 dhrs for the screws in this case could not be reviewed due to the lot numbers being unknown.There are no indications of manufacturing defects.For this part (99-6577) in the previous one year (from the notification date) regarding swelling, there is a complaint rate of 0.51% which is no greater than the occurrence listed in the application fmea.For this part (99-6577) in the previous one year (from the notification date) regarding scar tissue, there is a complaint rate of 0.09% which is no greater than the occurrence listed in the application fmea.For this part (99-6577) in the previous one year (from the notification date) regarding a loose screw, there is a complaint rate of 0.19% which is no greater than the occurrence listed in the application fmea.The most likely underlying cause of the complaint could not be determined.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.

Event Description

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

• Brand Name: TMJ SYSTEM CROSS DRIVE FOSSA SCREW 2.0MM X 7MM
• Type of Device: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10075496
• MDR Text Key: 191580385
• Report Number: 0001032347-2020-00240
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00841036057442
• UDI-Public: 00841036057442
• 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: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 99-6577
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention