MAUDE Adverse Event Report: SYNTHES GMBH TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM; PLATE, BONE

Catalog Number	04.503.206.01C
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Discomfort (2330); Swelling/ Edema (4577)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on an unknown date, both mandible plates were removed from the patient.The screws and, therefore, the plates had become loose.Some of the screws had backed out from the mandible.Rather than just removing some of the screws, the whole construct was removed.A sample of bone was sent for pathology.The patient experienced some mild discomfort and localized swelling.When the plates & screws were removed, bicortical screws were inserted to fixate the mandible.It was unknown if there were any patient consequences.This report is for one (1) unk - screws: cmf.This is report 1 of 2 for complaint (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.Investigation summary 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.D1, d2a, d2b, d3, d4, g4 ¿ 510k: this report is for an unknown screws: cmf/unknown lot.Part and lot numbers are unknown; udi number is unknown.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.
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.D2: additional procode: dzl.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 this medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
This is report 1 of 9 for complaint (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.H10 additional narrative: a2, a3: patient information added.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.B5: total number of reports in complaint updated.D10: concomitant devices updated.E1, e3: initial reporter updated.

• Brand Name: TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17669746
• Report Number: 8030965-2023-11092
• Device Sequence Number: 7105503
• Product Code: JEY
• UDI-Device Identifier: 10887587018812
• UDI-Public: (01)10887587018812
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K083388
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• 2 Devices were Involved in the Event: 1 2

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: 04.503.206.01C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2023
• Supplement Date Received by Manufacturer: 09/05/2023; 09/27/2023
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 09/20/2023; 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 MATRIXMIDFACE SCREW SELF-TAPPING 6MM; TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM; TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM; TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM; TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM; TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM; TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM; TRUMATCH MDFC/MND TI 3D PRNT PL/MND/MINI; TRUMATCH MDFC/MND TI 3D PRNT PL/MND/MINI; UNK - PLATES: MANDIBLE LOCKING; UNK - PLATES: MANDIBLE LOCKING; UNK - SCREWS: CMF
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 29 YR
• Patient Sex: Male