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 Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00201, 0001032347-2020-00202, 0001032347-2020-00204.Medical products: tmj system left narrow titanium mandibular component 45mm / 6 hole, part# 01-6546ti, lot# 907200.Tmj system left fossa component, small, part# 24-6563, lot# 933860c.Tmj system cross drive fossa screw 2.0mm x 7mm, part# 99-6577, lot# unk.2.4mm system 2.7mm x 10mm ht cross-drive screw,5/pk, part# 85-2710, lot# unk.The user facility is foreign; therefore, a facility medwatch report will not be available.Foreign report source: (b)(6).
Event or Problem Description
It was reported the patient will undergo a revision of temporomandibular joint implants on the left side due to trauma following a falling accident.A ct scan revealed the mandible bone fractured around the implant and the implant is displaced.The devices will be explanted and replaced with a custom implant.No additional patient consequences have been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is considered to be confirmed because a plan for a revision surgery was reported and a replacement custom tmj device was ordered.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 is the patient's reported accident.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.

• 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
• MDR Report Key: 9940268
• Report Number: 0001032347-2020-00203
• Device Sequence Number: 11458862
• Product Code: JEY
• UDI-Device Identifier: 00841036057442
• UDI-Public: 00841036057442
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K910038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2020

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?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 03/27/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 09/28/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention