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

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

Patient Problems Paralysis (1997); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for unknown plates.Part#, lot# and udi # is not available.Device is not expected to be returned for manufacturer review/investigation.This report is for unknown plates.Pma/510(k) number is not available.(b)(4).Product was not returned.Device history records review could not be completed without lot number.Based on the information available, it has been determined that no corrective and 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: sukegawa s et al (2019), which fixation methods are better between three-dimensional anatomical plate and two miniplates for the mandibular subcondylar fracture open treatment?, journal of cranio-maxillo-facial surgery, volume 47, issue 5, pages 771-777, https://doi.Org/10.1016/j.Jcms.2019.01.033 (japan).The purpose of the study is to compare the clinical outcomes of a single three-dimensional (3-d) anatomical plate versus two conventional straight miniplates for the open treatment of mandibular subcondylar fractures.From january 2009 to december 2017, 26 patients (28 fractures) with subcondylar mandibular fractures requiring open reduction and internal fixation (orif) surgery were included in the study.Patients were divided into 2 groups according to the material used for internal fixation: a 3-d plate (3-d) group (use of 3-d subcondylar plates) and a miniplate (mp) group (use of two straight titanium miniplates).The 3-d plate group consisted of 12 patients (13 fractures) with 7 males and 5 females and a mean age of 41.67 +/-21.66 years.These patients underwent a 1-plate fixation method and were implanted with an unknown synthes matrixmandible subcondylar plates system.The mp group consisted of 14 patients (15 fractures) with 9 males and 5 females and a mean age of 47.64 +/-22.93 years.These patients underwent a 2-plate fixation method and were implanted with an unknown synthes 2.0mm lock mandible miniplate and an unknown synthes 2.0mm matrixmandible miniplate.Patients were followed up postoperatively, and the functional status and incidence of treatment complications were assessed through clinical and radiographical examinations using a computed tomography (ct) or plain roentgenography at 1, 3, and 6 months postoperatively.Complications were reported as follows: (3d plate group)- a total of 3 patients had plate removal due to clinical symptoms.2 patients had plate breakage.1 patient had a plate breakage that was revealed during plate removal, but this complication did not affect bone healing.1 patient is a (b)(6) year-old male who had nonunion due to plate breakage.(fig.3 c) a postoperative 1.5-month panoramic x-ray photograph showed the 3-d lambda plate breakage and mesial dislocation of the subcondylar segment.This patient was revised with the 2-straight plate technique and showed good bone healing thereafter.1 patient had a foreign body sensation.The symptoms had improved by removing the plate after fracture healing.(mp group)- a total of 2 patients had plate removal due to clinical symptoms.1 patient had screw loosening but the fracture had been healing well.1 patient had a foreign body sensation.The symptoms had improved by removing the plate after fracture healing.2 patients had facial nerve paralysis.This report is for unknown plates.This is report 7 of 7 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 8638142
• MDR Text Key: 146056071
• Report Number: 8030965-2019-64487
• 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: 04/25/2019

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: 04/25/2019
• 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