MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: TITANIUM MESH IMPLANT; MESH, SURGICAL

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

Patient Problems Eye Injury (1845); Visual Disturbances (2140)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown titanium orbital mesh 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.

Event Description

This report is being filed after the review of the following journal article: tanaskovic n., et al (2019) periorbital reconstruction by ¿periorbital patch¿ technique using a pericardium-based collagen membrane and titanium mesh, materials volume 12 (15), pages 1-12 (bosnia and herzegovina).This study aims to determine if the placement of a collagen membrane over a titanium mesh can prevent the adhesion of orbital soft tissue for an improved clinical outcome.During the period of december 2011 and july 2015, 106 patients with orbital floor fracture were involved in this study.Seventy-two patients (55 males, 17 females) with an average age of 38 years were treated using only a titanium mesh, a titanium orbital mesh plate (synthes cmf, oberdorf, switzerland), for orbital wall reconstruction.12 reconstructive surgeries were performed using an auricular cartilage.This series of patients included nine males and three females, with an average age of 35 years.Cartilage grafts were placed on the healthy orbital edge, without being fixated to the base.22 patients (20 males, 2 females) with an average age of 37 years were treated with a combination of a pericardium-based collagen membrane (jason® membrane, botiss biomaterials gmbh, berlin, germany) and a titanium orbital mesh plate.The average length of hospitalization was two days with an average follow up period of 15 months.The following complications were reported as follows: for the first four patients treated with a collagen membrane in combination with the titanium mesh, this tissue was grafted over the ruptured periorbita with fixation to the collagen membrane that was partially covering the titanium mesh.In a six-month follow-up examination of these four patients, the presence of eyelids rigidity were observed.Treatment of the following eighteen patients was modified so that the titanium mesh was completely covered by the collagen membrane.Two patients postoperatively although they had no limitation to their ocular movements, there was a retraction of the lower eyelid.In titanium mesh group diplopia, extraocular movements (eom) limitation and rigidity of lids exhibited the highest rate of occurrences after six months.The frequency of diplopia, and eom limitation for patients treated with a titanium mesh covered with cartilage from the ear in the (12 patients) was 65% 50% , respectively , at first visit.The frequency of diplopia, eom limitation and rigidity of lids for patients treated with a titanium mesh covered with cartilage from the ear in the (12 patients) was 33%, 33%, and 16% , respectively , at 3 months and 33% , 33% and 25% at six months.The frequency of diplopia for patients treated with a titanium mesh covered with cartilage from the ear in the (12 patients) was 10% , at1 month.The frequency of diplopia, and extraocular movements (eom) restriction of patients treated with the titanium mesh and a collagen membrane (22 patients) was 68%, and 59% respectively at first visits.The frequency of rigidity of lids of patients treated with the titanium mesh and a collagen membrane (22 patients) was 9% at 1 month and 9% at 3 months.Severe eye motility : 12 at first visits, 3 at 3 months and 3 at 6 months.(for patients with for titanium meshes).Mild eye motility : 13 at first visits, 2 at 3 months and 3 at 6 months.(for patients with for titanium meshes).Severe eye motility : 1 at first visits, 2 at 3 months and 2 at 6 months.(for patients treated with ear cartilage).Mild eye motility : 2 at 3 months and 2 at 6 months.(for patients treated with ear cartilage).This report is for an unknown titanium orbital mesh plates (synthes cmf).This is report 1 of 2 for (b)(4).

• Brand Name: UNK - PLATES: TITANIUM MESH IMPLANT
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12330827
• MDR Text Key: 266890634
• Report Number: 8030965-2021-06733
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: BK
• 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: 07/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• 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: 07/25/2021
• 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