MAUDE Adverse Event Report: SYNTHES GMBH MATRIX; PLATE, BONE

Catalog Number	04.511.206.01
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Swelling/ Edema (4577)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H11: additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.H3, h6: product was not returned.Based on the information available, it has been determined that no corrective and 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.
Event or Problem Description
It was reported that on (b)(6) 2022 the patient underwent a procedure, implanting plates and screws in the mandible and maxilla.On (b)(6) 2022, the patient was admitted to the hospital due to pain, swelling and diagnosed with infection.On (b)(6) 2022 the patient underwent an i&d procedure.During that procedure, it was discovered a screw was loose in the right mandible.The loose screw was removed.Additionally, one plate and three other screws were removed, but there was no specific allegations against those devices.All other implants remained.

• Brand Name: MATRIX
• 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: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 25548422
• Report Number: 8030965-2026-06329
• Device Sequence Number: 18824226
• Product Code: JEY
• UDI-Device Identifier: 10887587023458
• UDI-Public: (01)10887587023458
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• 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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 04.511.206.01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown