MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SYNPOR IMPLANTS; MESH, SURGICAL

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

Patient Problems Eye Injury (1845); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.This report is for an unknown synpor implant/unknown lot.Part and lot number are unknown; udi number is unknown.Implant date is between (b)(6) 2000 to (b)(6) 2016.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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: fernandes lopes morais d'autilio, m.Et al (2019), incidence and prevention of cicatricial scleral show in the subciliary access in patients with orbital fractures, the journal of craniofacial surgery, vol.30 (6), pages 1782-1786, https://hsrc.Himmelfarb.Gwu.Edu/smhs_surgery_facpubs/1420/ (italy).The aim of this study is to evaluate, in our patients, the incidence of cicatricial scleral show using subciliary access in orbital fracture, and to demonstrate the efficacy of tarsal sling canthopexy for prevention of scleral show.Between january 2000 to december 2016, a total of 50 patients (26 male and 24 female), with a total of 67 eyes, with an average age of 55±5 years were included in the study.These patients underwent to orbital fractures reduction and reconstruction and were divided equally in 2 groups: group 1, subciliary approach and reconstruction of orbital floor without simultaneous tarsal sling canthopexy; group 2: reconstruction of orbital floor through subciliary approach with simultaneous tarsal sling canthopexy.Surgery was performed using porous polyethylene synpor.Follow-up was performed at 1, 3, 6, and 12 months.The following complications were reported as follows: a (b)(6) year-old male patient was noted to have scleral show.His picture illustrates that evident retraction is consequence of the structural weakening of lateral retinaculus.Notice discrepancy between pupils margin centers (bi- pupillary distance = 57.912 mm).Regarding the photographic-clinical examination and eyelid morphometry of the treated eye, bci, ifp, tl/tm measurements, in both groups, showed an increase in retraction within the first 3 months of post-surgery treatment.After this period, average reduction was 2.21 mm, 1.78 mm, and 2mm respectively.The inclination of palpebral fissure ¿¿ifp¿¿ increased progressively.Group 1 had a progressive increase during 12-month timeframe.Group 2 decreased during the cicatricial phase and increased until modest symmetry.The bci (distance between lower iris margin and lower ciliary border) starts pre-surgery at 2.7 and 2.64 for group 1 and 2 respectively and after 3 months group 1 increases to 2.9130 and group 2, instead, decreases to 2.61.After 12 months, both groups present a discreet decrease but group 1 noted supplementary morphometric difference even if in a modest entity (fig.2b).All patients, in both groups, had a determined retraction level in the first 3 months of post-surgical treatment (fig.2c).Entity of ptosis was determined by lower reflex margin distance (dmri) and percentage of lower lateral ptosis for group 1 was about 98.2%, even after 1 year.Regarding group 2, eyelid retraction occurred only in the first 3 months, during the cicatrization period, but after a year, this condition has disappeared.This report is for an unknown synthes synpor.This report is for one (1) unknown synpor implants.This is report 1 of 2 for (b)(4).

• Brand Name: UNK - SYNPOR IMPLANTS
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 10009307
• MDR Text Key: 194377931
• Report Number: 8030965-2020-03177
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2020
• 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: 04/23/2020
• 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
• Patient Age: 37 YR