MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM VA-LCP PROX TIBIA PLATE LARGE BEND/14H/237MM/RIGHT; PLATE, FIXATION, BONE

Model Number	02.127.360
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Irritation (1941); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Patient identifier listed as (b)(6); patient age and weight unavailable for reporting it is unknown when irritation began implant date is unknown device is not expected to return for investigation patient code is for additional medical intervention required.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.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 had to undergo a revision surgery on (b)(6) 2018, for removal of a plate and screws implanted on an unknown date.The patient wanted the plate and the screws to be removed as the plate was sticking out of the patient's skin.The implants were removed intact.Nothing was implanted back in the patient.The surgery was completed without any delay and the patient was stable after the surgery.This is report 1 of 2 for (b)(4).

• Brand Name: 3.5MM VA-LCP PROX TIBIA PLATE LARGE BEND/14H/237MM/RIGHT
• 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: 7433673
• Report Number: 2939274-2018-51725
• Device Sequence Number: 1476338
• Product Code: HRS
• UDI-Device Identifier: 10886982044006
• UDI-Public: (01)10886982044006
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K120689
• 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): 03/27/2018

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: 02.127.360
• Device Catalogue Number: 02.127.360
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/27/2018
• 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