MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5 VACRVD CONDY PL/10H/230/RT; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Model Number 02.124.410

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient age was not available for reporting.Unknown when infection began.Additional product code: hwc.There is no allegation of a product malfunction against this device; however, because this device is dwelling in the area of the reported event it cannot be disassociated from the reported adverse event complainant part is not expected to be returned for manufacturer review/investigation.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.Product was not returned and no lot number was provided.Based on the information available, 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the patient underwent removal of two 3.5mm attachment plates ,five 5.0mm locking screws, four cables, one plate and eight 3.5mm locking screws on (b)(6) 2018 due to infection.A pus came out when patient was opened.A removal and debridement were performed.The hardware was originally implanted on (b)(6) 2013.The revision surgery was completed without any complications and without any surgical delay.Patient status following the procedure was reported as stable.This complaint involves six (6) devices.This report is 1 of 6 for (b)(4).

• Brand Name: 4.5 VACRVD CONDY PL/10H/230/RT
• Type of Device: IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7375060
• MDR Text Key: 103609837
• Report Number: 2939274-2018-51247
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 10886982042811
• UDI-Public: (01)10886982042811(10)LOTUNK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/27/2018

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
• Device Operator: Health Professional
• Device Model Number: 02.124.410
• Device Catalogue Number: 02.124.410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2018
• Initial Date FDA Received: 03/27/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 48