MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; PLATE, FIXATION, BONE

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

Patient Problems Nerve Damage (1979); Paralysis (1997)

Event Type  Injury  

Manufacturer Narrative

This report is for a synthes ao locking mini plates/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

This report is being filed after the review of the following journal article: tomoaki imai et.Al (2019), surgical approaches for condylar fractures related to facial nerve injury: deep versus superficial dissection, international journal of oral & maxillofacial surgery, pages 1-8 (japan)doi.Org/10.1016/j.Ijom.2019.02.003.The aim of this article is to investigate the probability of facial nerve injury (fni) in the treatment of condylar neck and subcondylar fractures (cn/scfs) with percutaneous approaches and to identify factors predicting fni.Between january 2010 to august 2018, a total of 80 patients with 87 fractures were 73 patients underwent unilateral and 7 patients underwent bilateral surgery (50 male and 30 female) with a mean age of 46.3 years were included in the study.The patients were divided into groups according to facial nerve injury presence or absence at 1 week after surgery.In all the approach the plates used were ao locking miniplates or matrix mandible was place along the ramus.The mean duration of follow-up was unknown.The following complications were reported as follows: of the 22 patients (27.5%) with fni, 7 (31.8%, or 8.8% of the total study patients) had prolonged paralysis for more than 3 months.Of the prolonged paralysis cases, 2 (28.6%, or 2.5% of the total study patients) treated using the traditional submandibular approach (i.E., deep group) also had paralysis of the mmb at their 6-month visit.Plate breakage occurred in 1 patient with a displaced condylar neck fracture.This report is for a synthes ao locking mini plates.This is report 1 of 9 for (b)(4).

• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8636560
• MDR Text Key: 145945785
• Report Number: 8030965-2019-64428
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2019
• 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
• Date Manufacturer Received: 04/24/2019
• 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