MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/RIGHT; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Model Number 02.124.414

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Impaired Healing (2378)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).Date of event: unknown date in 2017.Additional product codes: hrs, hwc.Implant date: unknown date in (b)(6) 2017.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.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 Description

It was reported that patient had an open reduction internal fixation revision on (b)(6) 2017 for a broken plate and nonunion.It is unknown the exact date of implantation but it is thought that it was sometime in (b)(6) 2017.Procedure was completed successfully with a positive patient outcome.Concomitant device(s) reported: screws (part/lot unknown, quantity unknown).This is report 1 of 1 for (b)(4).

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/RIGHT
• 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: 7164067
• MDR Text Key: 96365337
• Report Number: 2939274-2018-50070
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 10886982042897
• UDI-Public: (01)10886982042897(10)LOTUNKNOWN
• 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: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.124.414
• Device Catalogue Number: 02.124.414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2017
• 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 Age: 61 YR
• Patient Weight: 154