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

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

Patient Problems Visual Impairment (2138); No Code Available (3191)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown plates: trauma/unknown lot number.Without the specific part number, the udi number and 510k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number, the device history records review could not be completed as no product was received.Investigation summary product was not returned.Based on the information available, it has been determined that no corrective and preventive 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

Device report from korea, south reports an event as follows:this report is being filed after the review of the following journal article: kyu jin chung et, al (2016), correction of medial blowout fractures according to the fracture types, annals of plastic surgery vol.76 no.1, pages 46-50 (korea, south).Doi:10.1097/sap.0000000000000560.The aim of this study is to classify the types of medial orbital wall fractures and to suggest appropriate guidelines for the selection of an appropriate technique for each category.Between 2010 and march 2013, a total of 89 patients (67 males and 22 females) with a mean age of 36.1 years (range, 11-71 years) were included in the study.These patients were classified into 3 different categories: greenstick, simple, and complex.In simple fractures type ii, the defects were reconstructed by applying for a 0.8-mm-thin titanium-reinforced fan plate.For complex fracture, the 3-mm-thick porous polyethylene plate was inserted into the fractured site.The mean duration of follow-up was 7.4 months.The following complications were reported as follows: 2 patients had diplopia and limitation of eyeball movement in type ii patients.2 diplopia and 1 eyeball movement limitation postoperatively in type iii patients.1 patient in type i, suffered 2 mm enophthalmos 3 months after the operation.2 patients in type iii, complained of residual presence of enophthalmos after the operation.The 2 patients had 2 mm enophthalmos without discomfort in cosmetic outcomes.Of the 3 pieces of implant that had been inserted, one was removed resulting in resolution of the eyeball movement limitation (table 1).This report is 3 of 4 for (b)(4).This report is for a 0.8-mm-thin titanium-reinforced fan plate and 3-mm-thick porous polyethylene plate.

• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6103142063
• MDR Report Key: 8890985
• MDR Text Key: 154727198
• Report Number: 8030965-2019-67198
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• 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: 07/17/2019
• 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