MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 95 DEG CONDYLAR PLATE 18 HOLES/80MM/299MM-STERILE; APPLIANCE,FIXATION,NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT

Model Number	237.86S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight was not provided.Date of event is unknown.Date of implant is an unknown date in 2016.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, 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 95-degree condylar plate and nine 4.5 mm cortical screws were originally implanted in 2016 due to an unknown reason.Subsequently, antibiotic beads were placed in the area approximately one year ago due to infection.Patient underwent a hardware removal on (b)(6) 2018 due to ongoing infection.It was the patient¿s decision to have the hardware removed.The hardware was removed fully intact.Nothing untoward occurred during the removal procedure.The procedure was completed successfully with the patient in stable condition.There is no evidence that the explanted hardware was related to the ongoing infection.The reporter was not aware of any patient symptoms.This report is for one (1) 95 deg condylar plate 18 holes/80 mm/299 mm-sterile.This is report 1 of 2 for (b)(4).

• Brand Name: 95 DEG CONDYLAR PLATE 18 HOLES/80MM/299MM-STERILE
• Common Device Name: APPLIANCE,FIXATION,NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7433253
• Report Number: 2939274-2018-51722
• Device Sequence Number: 11160856
• Product Code: KTW
• UDI-Device Identifier: 10886982161567
• UDI-Public: (01)10886982161567
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K914546
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2018

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: 237.86S
• Device Catalogue Number: 237.86S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2018
• Initial Report FDA Received Date: 04/16/2018
• 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: 54 YR