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

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Bacterial Infection (1735); Failure of Implant (1924); Cancer (3262)

Event Date 04/06/2021

Event Type  Injury  

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 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 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
• Type of Device: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11648748
• MDR Text Key: 244890910
• Report Number: 0001032347-2021-00187
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00841036130558
• UDI-Public: (01)00841036130558(10)978940
• Combination Product (y/n): N
• PMA/PMN Number: K063052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention