MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PEDIATRIC LCP CONDYLAR PLATE 5.0MM/90°/5 HOLES; PLATE, FIXATION, BONE

Model Number	02.108.421
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This patient information is unknown.Date of event: unknown.Additional device product code: hwc.Original implant date is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 the patient underwent revision surgery on (b)(6) 2018 due to fibrous dysplasia which eventually led to hip falling into extreme varus.Patient previously had an osteotomy, on an unknown date, and was implanted with a pediatric locking compression plate (lcp) condylar plate, four (4) unknown locking screws and four (4) unknown cortex screws.During the revision, the plates and screws were taken out successfully and section of the fibrous dysplasia was taken out.The patient's new osteotomy was then corrected with a custom retrograde nail.The procedure was completed successfully.It is unknown if there was a surgical delay.Patient outcome reported as good.This report is for one (1) pediatric lcp condylar plate 5.0 mm/90°/5 holes.This is report 1 of 3 for (b)(4).

• Brand Name: PEDIATRIC LCP CONDYLAR PLATE 5.0MM/90°/5 HOLES
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7706348
• Report Number: 2939274-2018-52991
• Device Sequence Number: 1511031
• Product Code: HRS
• UDI-Device Identifier: 10886982030115
• UDI-Public: (01)10886982030115
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K112085
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/29/2018

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: 02.108.421
• Device Catalogue Number: 02.108.421
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2018
• Initial Report FDA Received Date: 07/20/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention