MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM CROSS DRIVE EMERGENCY FOSSA SCREW 2.3MM X 7MM; PLATE, BONE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Pain (1994); Inadequate Pain Relief (2388)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (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: 0001032347-2020-00352, 0001032347-2020-00354, 0001032347-2020-00355, 0001032347-2020-00356 medical products: 2.4mm system high torque (ht) cross-drive screw 2.7 x 10mm, part# 91-2710, lot# ni; tmj system cross drive emergency fossa screw 2.3mm x 7mm, part# 99-6587, lot# ni; tmj system cross drive fossa screw 2.0mm x 7mm, part# 99-6577, lot# ni; tmj system left narrow mandibular component 45 mm / 6 hole, part# 01-6546, lot# 694740; tmj system left fossa component, small, part# 24-6563, lot# 826700.Occupation ¿ patient.
Event or Problem Description
It was reported by the patient that they are experiencing various issues following implantation of temporomandibular joint implants on the left side approximately eleven (11) years ago.The implanting surgeon reports that there were no issues with the implants during follow-up appointments.The patient reports a gash on the inside of the right cheek.The patient has received nerve blocks that are inadequate in providing pain relief.The patient reports seeing a neurosurgeon for a neurostimulator implant to treat pain.No additional patient consequences have been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is confirmed because additional measures were reported to have been taken to help the patient manage her pain.No product was returned as the devices remain implanted, 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 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 follow-up report is being submitted to relay additional information.
Event or Problem Description
No further event information available at the time of this report.
Event or Problem Description
It is further reported that the patient is still in pain and now has an implanted neuro stimulator with the leads going to the trigeminal nerve and to the back of her head to alleviate severe headaches.
Additional Manufacturer Narrative
This report is being submitted to update additional information in section b4, b5, g3, e1, e2, e3, g2, g6, h2, h6, h10.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H3: insufficient information provided.This report was filed in error.There is no indication that this device caused or contributed to the event reported in 0001032347-2020-00355 and 0001032347-2020-00356; therefore, this product would not be considered reportable.H3 other text : see h10 narrative.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: TMJ SYSTEM CROSS DRIVE EMERGENCY FOSSA SCREW 2.3MM 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: 10367770
• Report Number: 0001032347-2020-00353
• Device Sequence Number: 972441
• Product Code: JEY
• UDI-Device Identifier: 00841036057473
• UDI-Public: 00841036057473
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K910038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/20/2023

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: 99-6587
• 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: 07/24/2020
• Supplement Date Received by Manufacturer: 01/07/2021; 08/12/2022; 06/14/2023; 10/04/2023
• Initial Report FDA Received Date: 08/05/2020
• Supplement Report FDA Received Date: 01/22/2021; 09/08/2022; 07/13/2023; 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Sex: Unknown