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

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (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: 0001032347-2020-00194, 0001032347-2020-00195, 0001032347-2020-00196.Medical products: tmj system left narrow mandibular component 50mm / 7 hole, part# 01-6551, lot# 723470a.Tmj system left fossa component, small, part# 24-6563, lot# 726780a.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.Occupation: patient.
Event or Problem Description
It was reported by the patient that she underwent surgery to correct issues with her jaw following implantation of temporomandibular joint implants on the left side three (3) years ago.The patient also reports pain so severe that she can barely open her mouth.Attempts have been made but no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is considered to be confirmed, because an additional surgery was performed to fix the patient's reported jaw issues.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 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 or Problem Description
This follow-up report is being submitted to relay additional information.
Additional Manufacturer Narrative
This report is being submitted to update additional information in section a3, b4, b5, e1, e2, e3, g3, g6, h2, h6 and h10.
Event or Problem Description
It is further reported that the patient has scar tissue against left joint replacement causing misalignment and creating a scissor bite.Her right side joint is being affected by compensation for the left side implant issues.No further intervention has been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records, lot identification was not provided for the screws.A definitive root cause cannot 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 or Problem Description
No further event information is available at the time of this report.
Event or Problem Description
It was further reported that the patient is being planned for a revision to a new custom implant.
Additional Manufacturer Narrative
Upon reassessment of the reported event based on additional information, this product did not cause or contribute to the reported event.This initial report submitted needs to be voided.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.This report is being submitted to update additional information in sections b4, b5, g3, g6, h2, and h11.
Event or Problem Description
It was reported by the patient that she underwent an unknown surgery to correct issues with her jaw following implantation of temporomandibular joint implants on the left side three (3) years ago.The patient also reports pain so severe that she can barely open her mouth.It was further reported that the patient has scar tissue against the left joint replacement causing misalignment and creating a scissor bite.Her right side joint is being affected by compensation for the left side implant issues.It was also further reported that the patient is being planned for a revision to a new custom implant.However, no revision procedure has been reported to date.Attempts have been made and no further information has been provided.

• Brand Name: TMJ SYSTEM CROSS DRIVE FOSSA SCREW 2.0MM X 7MM
• Common Device Name: PLATE, 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: jennifer delaney ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 9920593
• Report Number: 0001032347-2020-00197
• Device Sequence Number: 3257327
• Product Code: JEY
• UDI-Device Identifier: 00841036057442
• UDI-Public: 00841036057442
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K910038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/22/2024

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 99-6577
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/25/2020
• Supplement Date Received by Manufacturer: 09/28/2020; 11/28/2022; 01/26/2023; 02/12/2024; 04/12/2024
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 09/28/2020; 12/28/2022; 02/10/2023; 03/08/2024; 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female