MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM VA-LCP PROX TIBIA PLATE SMALL BEND/6H/117MM/LEFT; PLATE,FIXATION,BONE

Model Number	02.127.221
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code: hwc.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.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, the patient underwent removal of one (1) variable angle-locking compression plate (va-lcp) proximal tibia plate, small blend, four (4) variable angle (va) locking screws, four (4) cortex screws due to infection.All hardware was intact.Original implant was on (b)(6) 2016.Procedure was successfully completed with no surgical delay.Patient status is unknown.This report is for one (1) 3.5mm va-lcp prox tibia plate small bend/6h/117mm/left.This is report 1 of 3 for (b)(4).

• Brand Name: 3.5MM VA-LCP PROX TIBIA PLATE SMALL BEND/6H/117MM/LEFT
• 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: 8503894
• Report Number: 2939274-2019-57431
• Device Sequence Number: 18881477
• Product Code: HRS
• UDI-Device Identifier: 10886982043528
• UDI-Public: (01)10886982043528
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K120689
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/19/2019

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: 02.127.221
• Device Catalogue Number: 02.127.221
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 04/11/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 29 YR
• Patient Weight: 78