MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP LOW BEND MEDIAL DSTL TIBIA PLATE/8H/RIGHT/161MM; PLATE,FIXATION,BONE

Model Number	02.112.518
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
Implant date (b)(6) of an unknown year.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.Patient code (b)(4) used to capture additional medical/surgical intervention required.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 hardware implantation on (b)(6), of an unknown year.On an unknown date, the patient underwent hardware removal of locking compression plate (lcp) low bend medial distal tibia plates, locking compression plate (lcp) one-third tubular plates with collar, and an unknown number of unknown screws.The removal of devices were due to infection and tissue sloughing.Procedure and patient outcome are unknown.This report is for one (1) 3.5mm lcp low bend medial dstl tibia plate/8h/right/161mm.This is report 1 of 3 for (b)(4).

• Brand Name: 3.5MM LCP LOW BEND MEDIAL DSTL TIBIA PLATE/8H/RIGHT/161MM
• 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: 7952035
• Report Number: 2939274-2018-54283
• Device Sequence Number: 1465194
• Product Code: HRS
• UDI-Device Identifier: 10886982034557
• UDI-Public: (01)10886982034557
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K013248
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2018

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: 02.112.518
• Device Catalogue Number: 02.112.518
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 10/10/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention