MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM VA-LCP CURVED CONDYLAR PLATE/6 HOLE/159MM/LEFT; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Model Number	02.124.407
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code: hwc, hrs.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot: part: 02.124.407, lot: 9505744, manufacturing site: (b)(4), release to warehouse date: june 15, 2015.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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
T was reported that on (b)(6) 2019, patient underwent hardware removal of two (2) variable angle locking compression plate (va-lcp) condylar plate and sixteen (16) unknown locking screws due to pain.Originally, the patient had bilateral osteotomies on unknown date.However, the patient was experiencing pain when performing squats.Thus, removal was done successfully.There was no patient consequence reported.This is report 2 of 10 for (b)(4).Related product complaint: (b)(4).

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/6 HOLE/159MM/LEFT
• Common Device Name: IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9596265
• Report Number: 2939274-2020-00220
• Device Sequence Number: 2499511
• Product Code: JDP
• UDI-Device Identifier: 10886982042750
• UDI-Public: (01)10886982042750
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K110354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/23/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: 02.124.407
• Device Catalogue Number: 02.124.407
• Device Lot Number: 9505744
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2019
• Initial Report FDA Received Date: 01/16/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 18 YR
• Patient Weight: 137