MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; CERCLAGE FIXATION

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

Patient Problem Chest Pain (1776)

Event Type  Injury  

Manufacturer Narrative

Patient information is not available for reporting.Date of event: unknown.This report is for an unknown synthes zipfix sternal closure system/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(510k): unknown, as specific part and lot numbers for zipfix is not provided.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.[(b)(4) lequaglie et al 2012.Pdf].

Event Description

This report is being filed after the review of the following journal article: lequaglie c, giudice g, marasco, rd, moret ad (2012).Stabilization after trauma and/or surgery: zipfix® system versus standard techniques.Cardiothoracic surgery.Volume 142.Number 4 meetingabstracts.(italy).The purpose of this study is to evaluate the effectiveness of the new system of sternal stabilization named zipfix® (synthes) similar for the use of cable ties in poly-ether-ether- ketone (peek), biocompatible and radiolucent (no-scattering rx standard, ct and mri).This study aims to bring the benefits in terms of results in the short and long term duration or cost of the procedure and hospital stay, functional restoration even in patients at risk of dehiscence (osteoporosis, kidney failure, diabetes, copd, hemorrhage, reoperation, mechanical ventilation, tracheotomy, radiation, obesity).In 2011, 6 patients implanted with an unknown synthes zipfix system for the synthesis of longitudinal median sternotomy were included in the study.The cable ties were implanted through the intercostal space and in the parasternal in number of 3-5 from i to v space, according to the situation.The mean duration of implant procedure is 16 minutes.Post-operatively, all patients have excellent aesthetic results, functional restoration and were able to return to work after 40 days.Complications were reported as follows: short term results: chest pain treated with 30 mg of ketorolac for three times a day to the removal of any drainage.Long term results: 5 patients experienced chest pain lag for the first 3 months and controlled effectively by administering 500 mg of paracetamol.This report is for one device- unknown synthes zipfix system.This is report 1 of 1 for (b)(4).

• Type of Device: CERCLAGE FIXATION
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7582618
• MDR Text Key: 110493289
• Report Number: 8030965-2018-54213
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2018
• 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