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 Type  Injury  

Event Description

This report is being filed after subsequent review of the following literature article.Complications in endoscopic-assisted open reduction and internal fixation of mandibular condyle fractures.Kang et al, oral and maxillofacial surgery vol.113 no.2 february (2012) 201-206.Twenty-six patients underwent eaorif (endoscopic-assisted open reduction and internal fixation) for mandibular condyle fractures using a set of subcondylar/ramus fixation systems (synthes, west chester, pa, usa) and intermaxillary fixation of the original contact teeth in the occlusion state was performed with intermaxillary fixation screws (synthes) or an arch bar.The postoperative follow-up period was longer than 6 months.We analyzed associations between the complication incidence and the number of fixation plates, accompanying mandibular fractures, and age.Complications within 3 months after surgery were defined as temporary complications; complications sustained for 3 to 6 months after surgery were defined as long-term complications.Bony fragment displacements found with different numbers of fixation plates.Twelve patients had an accompanying mandibular fracture.Eighteen patients had temporary complications, including wound infection, temporomandibular joint (tmj) problems, occlusion interference, and facial paresthesia or palsy.Six patients had long-term complications with slight premature contact of the teeth and slight over bite.Tmj pain or surgical site infections and limited mouth opening and lateral excursive movement of the mandible, and one patient received a reoperation do to refracture one month after surgery.Conclusion: in this study, the complication rates were not considered significant.The long-term complication rate was much lower than the temporary complication rate.Moreover, the symptoms of long-term complications were slight, except in cases where long-term complications were thought to be the result of malreduction or refracture.This is report 1 or 1 for (b)(4).This report is for two unknown fixation sets.

Manufacturer Narrative

This report is for two unknown fixation systems.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.

• Type of Device: SCREW FIXATION, INTRAOSSEOUS
• 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: 4286215
• MDR Text Key: 5082959
• Report Number: 2520274-2014-14714
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 11/10/2014

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: 11/10/2014
• Initial Date FDA Received: 12/01/2014
• 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