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

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

Patient Problem Visual Impairment (2138)

Event Type  Injury  

Manufacturer Narrative

Patient information is unknown.It is unknown when the event occurred.The 510k: this report is for a titanium mesh - unknown lot; unknown part.Udi number is unknown.Implant/explant date: unknown.Complainant part has not been returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

Event Description

This report is being filed after the subsequent review of the following literature article: pedemonte (2016) can customized implants correct enophthalmos and delayed diplopia in post-traumatic orbital deformities? international journal of oral maxillofacial surgery, volume 45, pages 1086-1094.Chile.The objective of this study was to determine whether orbital reconstruction with customized implants can correct post-traumatic orbital deformities such as late enophthalmos and delayed diplopia.The sample for this study was selected from the population of patients who underwent initial treatment for orbital fractures between january 1, 2011 and august 1,2014.A total of 153 patients, 137 men and 16 women with orbitozygomatic complex fractures were treated for a total of 168 fractured orbits.All 153 patients with a major trauma underwent orbital reconstruction using a two-dimensional (2d) titanium mesh (synthes, (b)(4)) or anatomical three-dimensional (3d) titanium mesh using the matrix orbital system (synthes, (b)(4)); in one case, titanium mesh plus high-density porous polyethylene was used (medportitan, stryker).Of the total number of orbits treated, 161 were reconstructed with mesh and/or osteosynthesis plates and did not require a secondary intervention.The following complications were observed.Seven patients - the titanium mesh was inadequate for the reconstruction support of the soft tissue due to the extension, comminution, and/or position of the fracture with the result being diplopia and/or enophthalmos.Out of these seven patients, five patients received customized wax-cast titanium implants (unknown manufacturer) and two received implants manufactured using cad/cam technology (unknown manufacturer): one made of titanium and the other of peek (unknown manufacturer).This report is for an unknown two-dimensional (2d) titanium mesh using the matrixorbital system (synthes, (b)(4)).This is report 1 of 2 for (b)(4).

• Type of Device: BONE PLATE
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7197402
• MDR Text Key: 97503284
• Report Number: 8030965-2018-50415
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: CI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention