MAUDE Adverse Event Report: SYNTHES MEZZOVICO 4.5MM VA-LCP CURVED CONDYLAR PLATE/16HOLE/336MM/RT-STER; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.124.416S

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.Additional product codes: hrs & hwc.(b)(4).Device is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history record review and 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 Description

Device report from synthes on an event in (b)(6) as follows: it was reported that (b)(6) rep has been notified that a va condylar plate has been revised with a retrograde nail post original surgery due to plate breakage.Patient was (b)(6) years old and the surgeon reported that the original fracture was a nasty long highly comminuted fracture.The surgeon emailed rep this information as a matter of interest and does not expect follow up at this point.Rep has asked for further details such as operation dates, patient co morbidities and if the product is available for investigation.At this point rep, does not expect to receive this information or the implant as this sounds like it occurred a while ago.Concomitant parts reported: unknown quantity of screws, part unk, lot unk.The initial operation was on (b)(6) 2017, the patient underwent revision surgery on (b)(6) 2017.The patient is female and was fully weight bearing given she was unlikely to cope with partial or touch weight bearing.The patient has no other specific comorbidities.This complaint involves one part.This report is 1 of 1 for (b)(4).

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/16HOLE/336MM/RT-STER
• Type of Device: IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer (Section G): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6793068
• MDR Text Key: 82655135
• Report Number: 1000562954-2017-10174
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.416S
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 96 YR