MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC MATRIXWAVE MMF TI PLATE 10 HOLES/TALL; BONE PLATE

Model Number	04.503.821
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight was not provided for reporting.Date of event is unknown.Device is not expected to be returned for manufacturer review/investigation.Reporter contact number was not provided.(b)(4).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.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 a patient underwent a procedure to repair an unknown mandible fracture on (b)(6) 2015.The patient had attempted to remove their own molar.Postoperatively, on (b)(6) 2015, it was identified that the patient had presented with non-union of the fracture site and an infection.On (b)(6) 2015, the patient was returned to the operating room where the surgeon removed two synthes matrixwave maxillomandibular fixation (mmf), and 12 unknown 6 mm screws.The fracture was noted to have fully healed at that time.The procedure was completed successfully.No surgical delays were reported.This report is for one (1) matrixwave mmf ti plate 10 holes/tall.This is report 2 of 3 for (b)(4).
Additional Manufacturer Narrative
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 a patient underwent a procedure to repair an angular mandible fracture on (b)(6) 2015.The fracture was fracture was non-discplaced and treated strictly with mandibulo-maxillary fixation.The patient had attempted to remove their own molar.Postoperatively, on (b)(6) 2015, it was identified that the patient had presented with non-union of the fracture site and an infection not near the construct.The unknown infection was treated with multiple courses of antibiotics and the the infected area was debrided and fixed with a bicortical recon bar.On (b)(6) 2015, the patient was returned to the operating room where the surgeon removed two synthes matrixwave maxillomandibular fixation (mmf), and 12 unknown 6mm screws.The fracture was noted to have fully healed at that time.The procedure was completed successfully.No surgical delays were reported.

• Brand Name: MATRIXWAVE MMF TI PLATE 10 HOLES/TALL
• 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: 7146297
• Report Number: 2939274-2017-50426
• Device Sequence Number: 927774
• Product Code: JEY
• UDI-Device Identifier: 10887587069449
• UDI-Public: (01)10887587069449(10)LOT#UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141165
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2017

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
• Operator of Device: Health Professional
• Device Model Number: 04.503.821
• Device Catalogue Number: 04.503.821
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/28/2017
• Supplement Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 12/26/2017
• Supplement Report FDA Received Date: 01/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR