MAUDE Adverse Event Report: SYNTHES GMBH TI MATRIXNEURO BOX PLATE 14MM X 14MM; PLATE, BONE

Catalog Number	04.503.065
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint#: (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that the patient had an initial cranial fixation with synthes cmf hardware in 2002, followed by additional procedures in 2006 and 2011.Over time patient developed hardware exposure of cranial titanium mesh/plates and eventually found a loose screw on the pillow (dec 2022).Clinical notes documented exposed screw and colonized exposed mesh/hardware.In 2023, surgeon performed removal of exposed titanium mesh and hardware, with rotational-advancement scalp flaps.Patient has undergone multiple revision surgeries over the years for hardware exposure and wound complications.Related complaints (b)(4) capture patient's additional surgeries.
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: added: d10 (concomitant) if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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: h6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TI MATRIXNEURO BOX PLATE 14MM X 14MM
• 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 wrights lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 23619643
• Report Number: 8030965-2025-11719
• Device Sequence Number: 10090460
• Product Code: JEY
• UDI-Device Identifier: 10887587017976
• UDI-Public: (01)10887587017976
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K123723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup

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: 04.503.065
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 12/03/2025; 12/15/2025
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 12/12/2025; 12/16/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TI MATRIXNEURO SCREW SELF-DRILLING 4MM.; TI MATRIXNEURO ULP BURR HOLE COVER 15MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown