MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC UNK - PLATES: MATRIX ORBITAL; PLATE, FIXATION, BONE

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

Patient Problems Eye Injury (1845); Pain (1994); Visual Disturbances (2140); Ptosis (2620); Not Applicable (3189); Eye Pain (4467)

Event Type  Injury  

Manufacturer Narrative

Patient information is unknown.Date of event: it is unknown when the event occurred.Pma / 510k: this report is for an unknown titanium mesh plate/unknown lot.Part and lot number are unknown; udi number is unknown.Implanted date: 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.(b)(4).

Event Description

This report is being filed after subsequent review of the following literature article: mackenzie, d: arora, b; hanse, j (1999) orbital floor repair with titanium mesh screen.Journal of cranio-maxillofacial trauma.5(3) 9-16.(usa) this is a retrospective study of 51 orbital floor fractures and surgical repair using titanium mesh screen (synthes, paoli, pa) without bone graft in 43 patients.A subciliary surgical approach was used in 24 orbits and transconjunctival surgical approach in 24 orbits.There were 3 patients with bilateral orbital floor injuries, where bone graft was placed on the mesh in one orbit to improve symmetry.Based on observation or measurements, no patients were over-corrected or proptotic.One patient with a 4 mm enophthalmos 7 months following surgery will require further evaluation and surgery to correct an inadequately reduced zygoma.One patient had a 3 mm hypoglobus on the operated side 9-month post-surgery.Two patients had prolonged pain that gradually improved over several months.Diplopia failed to resolve completely in 4 patients.One patient treated with a subciliary approach experienced ectropion and received operative repair while 4 others had transient ectropion or scleral show that resolved in 8 weeks.A copy of the article will be submitted with the medwatch.This is 1 of 1 for (b)(4).This report is for an unknown titanium mesh.This report is for 1 unknown patient who experienced 4 mm enophthalmos, 1 patient who experienced 3 mm hypoglobus, 2 patients that experienced prolonged pain, 1 patient that experienced ectropion with repair, and 4 patients that experienced transient ectropion or scleral show.

Manufacturer Narrative

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.

• Brand Name: UNK - PLATES: MATRIX ORBITAL
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE: SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 7151449
• MDR Text Key: 95944254
• Report Number: 2939274-2017-50466
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• 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: 02/19/2021
• 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