MAUDE Adverse Event Report: SYNTHES GMBH TI MATRIX OBL L-PL/3X3 H SHT/REVERS/0.7; PLATE, BONE

Catalog Number	04.511.324
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a data collection sheet was received which includes safety related data on matrix orthognathic.One 17-year-old female received osteotomy, le fort, with manibular sagittal split osteotomy bilateral for craniofacial reconstruction in mandible and experienced hardware failure and infection.This event is marked as related to matrix orbital (mo) implants, related to the index procedure and the cause for reoperation.Treatment was reoperation.This report is for an unknown matrix orbital plate.This is report 7 of 7 for (b)(4).Complaint (b)(4) captured the event involving the left side.Additional matrix orbital implants are captured on related complaint (b)(4) for the event involving the right side.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11: additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TI MATRIX OBL L-PL/3X3 H SHT/REVERS/0.7
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19721432
• Report Number: 8030965-2024-08537
• Device Sequence Number: 12830672
• Product Code: JEY
• UDI-Device Identifier: 10887587023977
• UDI-Public: 10887587023977
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K083388
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 04.511.324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TI MATRIX OBL L-PL/3X3 H SHT/REVERS/0.7; UNK - SCREWS: MATRIX ORBITAL; UNK - SCREWS: MATRIX ORBITAL; UNK - SCREWS: MATRIX ORBITAL; UNK - SCREWS: MATRIX ORBITAL; UNK - SCREWS: MATRIX ORBITAL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 17 YR
• Patient Sex: Female