MAUDE Adverse Event Report: BIOMET MICROFIXATION STR PLT 4HLE 2.0 LACTOSORB SYS; CRANIOFACIAL FIXATION PLATE, BIOABSORBABLE

Catalog Number	915-2110
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Loss of fracture reduction (4901)
Date of Event	07/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) g2: china it is unknown whether the device will be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that a patient underwent a revision procedure approximately 1 week post implantation due to plate fracture and mandibular fracture separation and displacement.The plate was replaced with titanium plating with no complications.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.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h11.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: comminuted fracture on the left side of the mandible with breakage of the original absorptive plate, displacement and separation of the fracture end observed intraoperatively and on ct imaging.Reportedly, postoperatively the patient still experienced limited mouth opening and closing.Local anesthesia infiltrated around the original incisional site and sutures removed.The tissue was separated to reveal the displaced broken section of the mandible and the internal fixation device fracture.The absorptive device was removed and the fracture end reset.Xrays were reviewed and not submitted for further assessment as the findings are documented within the provided records.A definitive root cause cannot be determined.The reported event is confirmed, based on medical records.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.

• Brand Name: STR PLT 4HLE 2.0 LACTOSORB SYS
• Common Device Name: CRANIOFACIAL FIXATION PLATE, 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: 22882746
• Report Number: 0001032347-2025-00350
• Device Sequence Number: 8861156
• Product Code: HRS
• UDI-Device Identifier: 00841036054557
• UDI-Public: (01)00841036054557(17)280103(10)65826392
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K971870
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2025

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: Lay User/Patient
• Device Catalogue Number: 915-2110
• Device Lot Number: 65826392
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2025
• Supplement Date Received by Manufacturer: 09/05/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Unknown