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

Device Problem No Apparent Adverse Event (3189)

Patient Problem Visual Impairment (2138)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown matrix midface/unknown lot.Part and lot numbers are unknown; udi number is unknown.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: zimmerer, r.M.Et al (2018), is there more to the clinical outcome in posttraumatic reconstruction of the inferior and medial orbital walls than accuracy of implant placement and implant surface contouring? a prospective multicenter study to identify predictors of clinical outcome, journal of cranio-maxillo-facial surgery, vol.46 (issue 4), pages 578-587 (switzerland).The aim of this prospective, controlled multicenter study is to identify potential predictors for unfavorable clinical outcomes 12 weeks postoperatively and to determine whether the type of implant used had an influence on the final contour of the implant.Between 2010 and 2014, a total of 144 patients (109 males and 35 females), with a mean age of 41.5 years, were included in the study.Surgery was performed using either of matrix midface preformed orbital plate, synpor titanium reinforced fan sheet or other competitor¿s device.The following complications were reported as follows: (the article did not specify the number of patients implanted with synthes devices) 24.3% of patients had double vision alone.4.2% of patients had difference in globe height or globe projection amounted to more than 2 mm without any associated diplopia.3.5% of patients suffered from a combination of diplopia and differences in globe height or globe projection >2mm.3.5% of patients had unclear results due to incomplete data.This report is for an unknown synthes matrix midface implant.This is report 3 of 3 for (b)(4).

• Brand Name: UNK - SYNPOR IMPLANTS
• 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: 8802813
• MDR Text Key: 151444451
• Report Number: 8030965-2019-66352
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• 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: 06/24/2019
• 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