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

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

Patient Problem Unspecified Infection (1930)

Event Date 09/15/2006

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.Additional narrative: the report is fro an unknown distractor/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.

Event Description

This report is being filed after the subsequent review of the following journal article, "cleft maxillary distraction versus orthognathic surgery: clinical morbidities and surgical relapse¿ cheung, l.K., chua, h.D.P.Hagg, m.B.(2006).American society of plastic surgeons 118:996-1008.Study conducted in (b)(4).The authors summarized the surgical experience and clinical results of 29 cleft and palate patients with moderate maxillary hypoplasia requiring a maxillary le fort i advancement of 4 to 10 mm were randomized into two groups for either internal maxillary distractors or immediate fragment transposition using miniplates and screw fixation.Results included: in the distraction group (synthes device), two of the 15 patients developed infection around the distractors and one patient had an occlusal relapse.One male patient presented with mucosal infection around the distractors during the activation period.The infection was controlled with intravenous antibiotics administered for a week.This is report 2 of 3 (reportable) for (b)(4).This report is for an unknown distractor.

• Type of Device: SCREW, FIXATION, INTRAOSSEOUS
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19341
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5226792
• MDR Text Key: 31316532
• Report Number: 2520274-2015-17291
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention