MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI MATRIXMAND 7X23 ANG RECON PL RT 2.5; PLATE, BONE

Model Number	04.503.740
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.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
It was reported that on an unknown date, patient underwent a hardware removal and replacement of milled plated required in or due to broken hardware will malocclusion teeth was experienced following broken mandible plate.Patient had previous mandible hardware that was implanted on (b)(6) 2020 following composite resection.A stock plate was implanted by the surgeon on said date with six (6) screws (3 on either side of osteotomy).Patient's plate had broken at the anterior bend.No screws had pulled out of the plate or bone.A new custom milled plate was implanted and repositioned the mandible back into occlusion following virtual occlusion by the surgeon.Concomitant device reported: unk - screws: matrixmandible (part# unknown; lot# unknown; quantity: 6); unk - extraction instruments: cmf.This report is for one (1) ti matrixmand 7x23 ang recon pl rt 2.5.This is report 1 of 1 for complaint (b)(4).

• Brand Name: TI MATRIXMAND 7X23 ANG RECON PL RT 2.5
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15084737
• Report Number: 2939274-2022-02864
• Device Sequence Number: 5101586
• Product Code: JEY
• UDI-Device Identifier: 10887587022888
• UDI-Public: (01)10887587022888
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K063790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/22/2022

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: 04.503.740
• Device Catalogue Number: 04.503.740
• Device Lot Number: H272598
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2017
• 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: UNK - EXTRACTION INSTRUMENTS: CMF; UNK - SCREWS: MATRIXMANDIBLE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female