MAUDE Adverse Event Report: SYNTHES USA; IMPLANT,FIXATION DEVICE,CONDYLAR PLATE

Device Problem Break (1069)

Patient Problems Death (1802); Failure of Implant (1924)

Event Date 02/07/2017

Event Type  Death  

Manufacturer Narrative

Device was used for treatment, not diagnosis.This report is for an unknown 4.5 mm variable angle locking compression plating system (b)(6).The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number or part number was provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Literature article received: "this report is being filed after the subsequent review of the following literature article: poole, w.Et al (2017).Modern distal femoral locking plates allow safe, early weight-bearing with a high rate of union and low rate of failure.The bone and joint journal, vol 99-b, 951-957.The united kingdom.This is a retrospective review of patients treated with a lateral distal femoral locking plate (ldflp) between 2009 and 2014 to describe the outcomes of fixation using modern implants within a strategy of early return to function.The study population included 122 patients (and a total number of 127 fractures).Patients (92 female) had a mean age of 72.8 years (range 16 to 101).107 patients were allowed to bear full weight immediately.The rate of clinical and radiological union was 81-85 (95%).Of the 127 patients: one (b)(6) male with a high energy fracture with medial comminution experienced a post operative break of a 16-hole variable angle condylar plate within one month of implantation.The patient was revised to a longer plate with shorter working length (5 hole).The patient died during the follow-up period.This is report 2 of 5 for (b)(4).This is for an unknown 4.5 mm variable angle locking compression plating system and refers to the serious injury and reportable malfunction (b)(6) man who experienced a post-operative break of an unknown 4.5 mm,16-hole variable angle condylar plate within one month of implantation.The patient was revised to a longer plate with shorter working length (5 hole).The patient died during the follow-up period.This report is for 1 device.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Other relevant history, including preexisting medical conditions.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment not diagnosis.Initial reporter's post office or zip code: (b)(6).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: IMPLANT,FIXATION DEVICE,CONDYLAR PLATE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6882208
• MDR Text Key: 86980971
• Report Number: 2520274-2017-12295
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/25/2017
• 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: 61 YR