MAUDE Adverse Event Report: SYNTHES USA; SCREW, FIXATION, BONE

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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

This report is being filed after subsequent review of the following journal abstract, "standardized three dimensionally preformed mandible reconstruction plates: preliminary clinical experience: (2011).Voss, p.J.Et al.(2011) standardized three dimensionally preformed mandible reconstruction plates: preliminary clinical experience.International journal of oral and maxillofacial surgery, 40 (10), 1044.A retrospective study was done on the clinical performance of three dimensionally preformed synthes matrix mandible reconstruction and the results presented at the international conference on oral and maxillofacial surgery.The study included 38 male and 28 female patients with a mean age of 61.2 years.The mean observation time was 8.7 months after plate insertion.One case developed a necrosis and infection which required the plate to be removed and three cases required plates to be removed due to infection or plate exposure.This is report 2 of 2 for (b)(4).This report for an unknown matrix mandible screw.

Manufacturer Narrative

Device used for treatment, not diagnosis.The mean age for patients is 61.2 years.Thirty eight male and 28 female patients in the study.Voss, p.J.Et al.(2011) standardized three dimensionally preformed mandible reconstruction plates: preliminary clinical experience.International journal of oral and maxillofacial surgery, 40 (10), 1044.This report if for an unknown matrix mandible screw/unknown quantity/unknown lot.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4347430
• MDR Text Key: 5174707
• Report Number: 2520274-2014-15513
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 12/03/2014
• Initial Date FDA Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention