MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH; MESH, SURGICAL

Device Problem Unintended Movement (3026)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: the average age in the pr group was 44 and 38 in the conventional group.This report is for an unknown synpor implant/unknown lot.Part and lot number are unknown; udi 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.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 subsequent review of the following literature article: young, c; et al (2017) the accuracy of patient specific implant presented with 3d-printed rapid prototype model for orbital wall reconstruction.Journal of cranio-maxillo-facial surgery, 45: 928-936.((b)(6)).This is a retrospective study to review 82 patients who underwent posttraumatic orbital wall fracture reduction between 2012 and 2014.Patients were divided into two groups according to the use of 3d-printed rp skull model reproduced by mirroring technique, onto which a titanium mesh was anatomically molded.Using computed tomographic scans, the areas of pre-and post-operative orbital wall defect, the layout angles of the titanium mesh, and the gap lengths between the implant and fracture margin were compared between the two groups.The average age in the pr group was 44 and 38 in the conventional group.We performed a computed tomography (ct) scan of all patients preoperatively on their first visit and postoperatively on the second day.A 3d simulation was performed using mimics 3d software (materialise (b)(4)).In all cases, a porous polyethylenecoated titanium mesh (synpor, synthes, inc., (b)(4)) was used to cover the area of the bone defect.In the rp group, the implant was pre-bent on the mirror-imaged 3d-reconstructed rp skull model.Then, the prebent implant was placed on the area of the bone defect under direct visualization of the fracture segment using the original rp skull model.The implant was fixed with 4- mm matrix midface screws (synthes, inc., (b)(4)).Whereas in the conventional group, the synpor implant was molded with a free-hand technique either the medial or inferior orbital rim according to the fracture type.Two patients in the rp group and 3 in the conventional group had mild enophthalmos, which partially improved over time.Two patients in the conventional group had moderate and severe enophthalmos, respectively.One patient in the rp group and 4 patients in the conventional group respectively had mild ocular limitation, which gradually resolved.Two patients in the conventional group who had moderate to severe enophthalmos and limited ocular motility underwent revision operation at 6 months postoperatively.In these patients, the malpositioned implant did not fully cover the bone defect and the entrapped soft tissue component was reduced.Two patients in the rp group and 5 patients in the conventional group had diplopia in some position of the gaze postoperatively.Of these, 2 patients in the rp group and 3 patients in the conventional group had complete resolution at 6-month follow up, and the other 2 patients in the conventional group had residual diplopia that required revision operation.(b)(4).This report is for an unknown synpor implant.This report is for synpor implant and 2 unknown patients experienced mod-severe enophthalmos, limited ocular mobility, malposition implant and underwent revision surgery.

• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf ; SZ
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7177844
• MDR Text Key: 96813315
• Report Number: 8030965-2018-50195
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2017
• 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