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

Model Number 04.503.556.01

Device Problem Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 01/01/2022

Event Type  Injury  

Event Description

Device report from australia reports an event as follows: it was reported that on an unknown date in 2022, a patient¿s mmf (matrixwave) screws pulled out, leading to the entire mandible being skewed.There was no reported pain or obvious signs of infection.The patient required a revision surgery to replace the screws, which was performed on (b)(6) 2023.No further information is available.This report is for a 2.0mm ti matrixmandible screw fine pitch / 6mm.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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.(b)(4).Event occurred on an unknown date in 2022.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.

• 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: 16408774
• MDR Text Key: 309896085
• Report Number: 8030965-2023-02049
• 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,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?: 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
• Initial Date Manufacturer Received: 01/27/2023
• Initial Date FDA Received: 02/21/2023
• Supplement Dates Manufacturer Received: 02/21/2023
• Supplement Dates FDA Received: 03/09/2023
• 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: TRUMATCH MDFC/MND TI 3D PRNT PL/MND/MINI
• Patient Outcome(s): Other
• Patient Age: 29 YR
• Patient Sex: Male