MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5/0.6 FLAT LEFORT PLATE; CRANIOFACIAL FIXATION PLATE, NON-BIOABSORBABLE

Catalog Number	01-6480
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 2.0/0.6 2mm chin plate, cat# 01-6452, lot# 187310.1.5 3/3 hole 100* left xlong l, cat# 01-7036, lot# 022550.1.5 3/3 hole 100* right xlongl, cat# 01-7037, lot# 886840.G2: brazil.Customer has indicated that the product is available to be 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: 0001032347-2023-00261.0001032347-2023-00263, 0001032347-2023-00264.
Event or Problem Description
It was reported that a patient underwent a revision procedure approximately 11 months post implantation due to fractured plate(s.) the components were removed.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10: medical product - zimmer biomet 1.5/0.6 flat lefort plate catalog #: 01-6480 lot #: 185770 qty: 2; zimmer biomet 2.0/0.6 2mm chin plate catalog #: 01-6452 lot #: 187310; zimmer biomet 1.5 3/3 hole 100* left xlong l catalog #: 01-7036 lot #: 022550; zimmer biomet 1.5 3/3 hole 100* right xlongl catalog #: 01-7037 lot #: 886840.Visual examination of the provided picture identified one of the plates is fractured.The photo shows all of the explanted devices, and one of the plates is clearly fractured.Medical records and radiographs were provided and reviewed by health care professionals.Review of the available records identified the following: contributing factors of this event include standard ii skeletal deformity and class ii occlusion.On clinical examination, the occlusion was stable but with abnormal maxillary mobility.Fracture of maxillary plates and pseudoarthrosis.Removal of plates, bone grafting, and fixation with new plates and maxillary screws.Panorex images were reviewed by a radiologist.Panorex image from 8/2/22 demonstrates multiple intact malleable plate and screw fixation devices involving the maxilla and mandible with metallic braces seen involving the maxillary and mandibular teeth.Panorex image from 2/7/23 demonstrates similar hardware with fractured malleable plates along the maxilla.Overall fit alignment of the implants is appropriate.Normal bone quality.No signs of loosening, wear, nonunion, malunion, radiolucency.No contributing factors seen.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated report: 0001032347-2023-00395.

• Brand Name: 1.5/0.6 FLAT LEFORT PLATE
• Common Device Name: CRANIOFACIAL FIXATION PLATE, NON-BIOABSORBABLE
• 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 rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17170845
• Report Number: 0001032347-2023-00262
• Device Sequence Number: 6574892
• Product Code: JEY
• UDI-Device Identifier: 00841036011673
• UDI-Public: (01)00841036011673(10)185770
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K121589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2023

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 01-6480
• Device Lot Number: 185770
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2023
• Supplement Date Received by Manufacturer: 07/07/2023; 10/26/2023
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 07/25/2023; 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2021
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 18 YR
• Patient Sex: Female