MAUDE Adverse Event Report: SYNTHES GMBH TI MATRIXNEURO CONTOUR MESH 200MM X 200MM/0.6MM RIGID; PLATE, BONE

Model Number	04.503.122
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exact date of event is unknown; event occurred on an unknown date in (b)(6) or (b)(6) 2018.Part number provided as 04.503.122 but unknown if it was the sterile or non-sterile part.Complainant part is not expected to be returned for manufacturer review/investigation.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.
Event or Problem Description
Device report from synthes (b)(4) reports an event as follows: it was reported that in (b)(6) or (b)(6) 2018 mesh collapse began.The mesh was originally implanted on (b)(6) 2016 due to a defect of the skull.In 2021, the patient reported the issue to the hospital.A ct was performed which confirmed the mesh was collapsed.The patient is stable so far.No other information provided.Further information could be added if provided.This report is for mesh.This is report 1 of 1 for (b)(4).
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.H10 additional narrative: b3 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 MATRIXNEURO CONTOUR MESH 200MM X 200MM/0.6MM RIGID
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12339067
• Report Number: 8030965-2021-06813
• Device Sequence Number: 3001926
• Product Code: JEY
• UDI-Device Identifier: 10887587018492
• UDI-Public: (01)10887587018492
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K042365
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2021

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 Model Number: 04.503.122
• Device Catalogue Number: 04.503.122
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2021
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 10/01/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention