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

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

Patient Problem Pressure Sores (2326)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following literature article, cousin, g.C.S.(2009).Wire-free fixation of jaw fractures.British journal of oral and maxillofacial surgeons 47:521-524.British article.The author summarized the surgical experience and clinical results of 151 successive patients treated by one experienced maxillofacial surgeon.Manual intraoperative reduction of some of the fractures was done during open reduction internal fixation (orif).Results included: a total of 150 successive patients had wire-free fixation of 146 mandibular and 5 maxillary fractures.Ninety-eight were hand-held in occlusion, and 52 were treated using rapid imf (synthes device).There were few complications.Patient had pressure ulcers on the gingivae.Patient smoked cigarettes.The patient had poor oral hygiene and developed ulcers and hyper plastic gingivitis that resolved when rapid imf was removed.This is report 7 of 7 (reportable) for (b)(4).This report is for an unknown rapid imf.

Manufacturer Narrative

Cousin, g.C.S.(2009).Wire-free fixation of jaw fractures.British journal of oral and maxillofacial surgeons 47:521-524.This report is for unknown rapid imf/unknown quantity/unknown lots.The 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: 4729771
• MDR Text Key: 5666528
• Report Number: 2520274-2015-13333
• 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: 04/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention