MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM CROSS DRIVE FOSSA SCREW 2.0MM X 9MM; PLATE, BONE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Scar Excision (2358); Inadequate Pain Relief (2388)
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: 0001032347-2020-00242, 0001032347-2020-00243, 0001032347-2020-00244, 0001032347-2020-00245, 0001032347-2020-00246, 0001032347-2020-00247.Medical products: tmj system right standard mandibular component 50mm / 9 hole, part# 24-6550, lot# 143380.Tmj system left standard mandibular component 50mm / 9 hole, part# 24-6551, lot# 164350.Tmj system right fossa component, small, part# 24-6562, lot# 328390.Tmj system left fossa component, small, part# 24-6563, lot# 212940.2.4mm system high torque (ht) cross-drive screw 2.7mm x 8mm, part# 91-2708, lot# unk.2.4mm system high torque (ht) cross-drive screw 2.7 x 10mm, part# 91-2710, lot# unk.Tmj system cross drive fossa screw 2.0mm x 9mm, part# 99-6579, lot# unk.Occupation: patient.
Event or Problem Description
It was reported the patient underwent a scar tissue removal procedure and currently undergoes pain management following implantation of bilateral temporomandibular joint implants twelve years ago.The patient reported a scar tissue removal procedure two (2) years ago.The patient attends a pain management consult every six (6) to eight (8) weeks.The patient has previously received cortisone shots and is currently on botox shots, celebrex and oxycodone.No additional patient consequences have been reported.
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.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.The database could not be reviewed for the screws involved in this case due to the lot numbers remaining unknown.There are no indications of manufacturing defects.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.

• Brand Name: TMJ SYSTEM CROSS DRIVE FOSSA SCREW 2.0MM X 9MM
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10112187
• Report Number: 0001032347-2020-00248
• Device Sequence Number: 3407887
• Product Code: JEY
• UDI-Device Identifier: 00841036057459
• UDI-Public: 00841036057459
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K910038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2020

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: 99-6579
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 11/05/2020
• 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