MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - PLATES: CMF; PLATE, FIXATION, BONE

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

Patient Problems Facial Nerve Paralysis (1846); Nerve Damage (1979)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown 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: bao, t.Et al (2019), quantitative assessment of symmetry recovery in navigation-assisted surgical reduction of zygomaticomaxillary complex fractures, journal of cranio-maxillo-facial surgery, volume 47(2), pages 311-319 (china).This retrospective study aims to quantitatively analyze the surgical results through the computation of asymmetry scores and measurement of orbital volumes.Between april 2012 and november 2016, a total of 25 patients (17 male and 8 female) with a mean age of 40.4 ± 11.36 years underwent oral and maxillofacial surgery.These patients were divided into 2 groups: navigation group consisted of 15 patients (10 male and 5 female) with a mean age of 41.06 ± 11.78 years while control group consisted of 10 patients (7 male and 3 female) with a mean age of 39.4 ± 10.62 years.Fractures were fixed using titanium plates and screws (synthes, zuchwil, switzerland).All patients were followed up in the 2nd week, 3rd month, 6th month, 12th month and 18th month postoperatively.The following complications were reported as follows: navigation group: 3 patients complained of temporary facial nerve injury, which resolved within 6 months.Control group: 2 patients complained of temporary facial nerve injury, which resolved within 6 months.3 patients complained of facial asymmetry in the zygion (z) area but refused surgical revision.This report is for an unknown synthes plates.It captures reported adverse events of facial nerve injury and facial asymmetry.This is report 1 of 2 for complaint (b)(4).

• Brand Name: UNK - PLATES: CMF
• 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: 8808643
• MDR Text Key: 151632076
• Report Number: 8030965-2019-66433
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2019
• 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: 06/26/2019
• 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