MAUDE Adverse Event Report: BIOMET MICROFIXATION TRAUMAONE SYSTEM 2.6MM LARGE ANGLE PLATE, STRAIGHT; PLATE, BONE

Model Number	N/A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Bacterial Infection (1735); Failure of Implant (1924); Cancer (3262)
Date of Event	04/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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: 0001032347-2021-00188.Implant date¿ implantation date was in (b)(6) 2019.Medical products: unknown screw, part# ni, lot# ni, qty: 7.Report source¿ (b)(6).
Event or Problem Description
It was reported the patient underwent a revision one (1) year following implantation of a mandible plate due to infection and one (1) loose screw.One (1) screw was found to have fallen off.In the revision, the surgeon removed the plate, debrided the area, and fixed it with a new plate.Attempts have been made and no further information has been provided.
Event or Problem Description
It was reported the patient underwent a revision six (6) weeks following implantation of a mandible plate due to suspected infection.One (1) screw was found to have fallen off.During the revision, the surgeon noted bone infiltration by cancer tissue rather than infection, and that the screw had fallen off due to softening of the tissue.The planned refixation was not performed to make a definitive diagnosis of the cancer by histological examination.Re-fixation is being considered at a later date.It was reported that no further information is available.

• Brand Name: TRAUMAONE SYSTEM 2.6MM LARGE ANGLE PLATE, STRAIGHT
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11648748
• Report Number: 0001032347-2021-00187
• Device Sequence Number: 11601929
• Product Code: JEY
• UDI-Device Identifier: 00841036130558
• UDI-Public: (01)00841036130558(10)978940
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K063052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2021

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: 44-1023
• Device Lot Number: 978940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 05/05/2021
• 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