MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0MM TI MATRIXMANDIBLE SCREW FINE PITCH / 6MM; BONE PLATE

Model Number	04.503.556.01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer 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.(b)(4).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 (b)(6) 2019, a titanium matrixmandible screw fine pitch that was placed into the mandible was fractured and broken after surgery.It is unknown if there was surgical delay.The fractured screw was then removed on (b)(6) 2019 from the plate.The broken screw pieces were removed from the patient easily.Procedure outcome and patient status are unknown.Concomitant devices: titanium matrixmandible 8h strut plate (part: 04.503.709, lot: unknown, quantity: 1).This report is for a 2.0 mm titanium (ti) matrixmandible screw.This is report 1 of 1 for (b)(4).

• Brand Name: 2.0MM TI MATRIXMANDIBLE SCREW FINE PITCH / 6MM
• Common Device Name: BONE PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8724008
• Report Number: 2939274-2019-58812
• Device Sequence Number: 1729906
• Product Code: JEY
• UDI-Device Identifier: 10887587021652
• UDI-Public: (01)10887587021652
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K121574
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/24/2019

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: 04.503.556.01
• Device Catalogue Number: 04.503.556.01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2019
• Initial Report FDA Received Date: 06/21/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TI MATRIXMANDIBLE PLATE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 21 YR