FDA Adverse Event Death Summary report: N

SCREW

MDR report key: 2771883 · Received September 27, 2012

Report

Report Number: 2520274-2012-02032
Event Type: Death
Date Received: September 27, 2012
Report Date: August 30, 2012
Product Code: JEY
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

E: ET.A: GERSON MAST, MD, DDS, MICHAEL ERMER, MD, DDS, RALF GUTWALD, MD, DDS, RAINER SCHMELZEISEN, MD, DDS, CHRISTOPH PAUTKE, MD, DDS, SVEN OTTO, MD, DDS, SEBASTIOAN SCHIEL, MD, DDS, MICHAEL EHRENFIELD MD, DDS, CARL-PETER CORNELIUS, MD, DDS AND MARC CHRISTIAN METZGER, MD, DDS. 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.

Description of Event or Problem · 1

A JOURNAL ARTICLE WAS RECEIVED: SURGICAL ONCOLOGY AND RECONSTRUCTION: MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATES - A TWO YEAR TWO INSTITUTION EXPERIENCE IN 71 PTS REPORTED: A STUDY WAS CONDUCTED FOR 71 SUBJECTS WITH INDICATION FOR A LOAD BEARING OSTEONECROSIS OF THE MANDIBLE. INDICATIONS FOR THE PLATE WERE DEFECTS DUE TO TUMOR, TRAUMA OR OSTEONECROSIS. THE MEAN AGE WAS 54.8 +/- 15.0 YEARS INCLUDING 43 MEN WITH MATRIX MANDIBLE PLATES PLACED IN 70 OF 71 PTS. THE FOLLOW UP PERIOD RANGED FROM 3 TO 26 MONTHS. OF THE 70 PTS 8 DIED. OF THESE PTS 1,2,3, ND 2 DIED 3,5,6, AND 9 MONTHS POSTOPERATIVELY, RESPECTIVELY, CONCLUSIONS OF STUDY: RESULTS OF STUDY SUGGEST THE USE OF MATRIXMANDIBLE PLATES COINCIDES WITH A REDUCED OPERATIVE TIME AND MINIMIZED RISK OF FATIGUE FRACTURES. THIS REPORT IS ON THE DEATH AT POST OPERATIVE IMPLANTATION AT 6 MONTHS. NO CAUSE OF DEATH WAS LISTED. THIS IS 2 OF 2 REPORTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1		SCREW	JEY

Patients

Seq	Age	Sex	Outcome	Treatment
1			Death\| R	PLATE\| SCREW