MAUDE Adverse Event Report: SYNTHES GMBH 2.0MM TI MATRIXMANDIBLE SCREW FINE PITCH / 6MM; PLATE, BONE

Model Number 04.503.556.01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Swelling/ Edema (4577)

Event Date 01/24/2023

Event Type  Injury  

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.Additional narrative: 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 Description

Device report from australia reports an event as follows: it was reported that on (b)(6) 2023, the patient complained of acute swelling in their right cheek and was admitted for antibiotics and eua.The pus seemed to be in the cheek but tracked from the plate.The plate was removed and soaked in peroxide and betadine, it was required to use slightly larger screws to replace the 6mm screws that were originally used.In the operating room prior to being anaesthetized, the patient complained that their left side was also becoming sore and that the skin on that side was starting to point.The mouth appears to have proof granulation tissue.This means that additional screws with 6-8-10mm lengths will need to be replaced with emergency 2.4 screws.No further information is available.This report is for a 2.0mm ti matrixmandible screw fine pitch / 6mm.This is report 10 of 13 for (b)(4).

• Brand Name: 2.0MM TI MATRIXMANDIBLE SCREW FINE PITCH / 6MM
• Type of Device: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• 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: 16372943
• MDR Text Key: 309504036
• Report Number: 8030965-2023-01827
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 10887587021652
• UDI-Public: (01)10887587021652
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K121574
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 04.503.556.01
• Device Catalogue Number: 04.503.556.01C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: MATMAND SCR Ø2 SELF-TAP L6 FINE-PITCH TH; MATMAND SCR Ø2 SELF-TAP L6 FINE-PITCH TH; MATMAND SCR Ø2 SELF-TAP L6 FINE-PITCH TH; MATMAND SCR Ø2 SELF-TAP L6 FINE-PITCH TH; MATMAND SCR Ø2 SELF-TAP L6 FINE-PITCH TH; MATMAND SCR Ø2 SELF-TAP L6 FINE-PITCH TH; MATMAND SCR Ø2 SELF-TAP L6 FINE-PITCH TH; MATMAND SCR Ø2 SELF-TAP L6 FINE-PITCH TH; MATMAND SCR Ø2 SELF-TAP L6 FINE-PITCH TH; MATMAND SCR Ø2 SELF-TAP L6 FINE-PITCH TH; MATMAND SCR Ø2 SELF-TAP L6 FINE-PITCH TH; MATMAND SCR Ø2 SELF-TAP L6 FINE-PITCH TH
• Patient Outcome(s): Required Intervention
• Patient Sex: Male