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

Device Problem No Apparent Adverse Event (3189)

Patient Problems Eye Injury (1845); Visual Impairment (2138)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown plate/unknown lot.Part and lot numbers are unknown; udi number is unknown.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: peng, m., merbs, s., grant, m.And mahoney, n.(2016), orbital fracture repair outcomes with preformed titanium mesh implants and comparison to porous polyethylene coated titanium sheets, journal of cranio-maxillo-facial surgery, vol.45(2), pages 271-274 (usa).The purpose of this study was to compare the outcomes of the matrixmidface titanium preformed orbital plate (pfti) (depuy synthes, west chester, pa, usa) and of our use of porous polyethylene coated titanium sheet (ppeti) (medpor titan barrier, stryker, kalamazoo, mi, usa) implants during the same time period.A total of 195 patients were treated with a matrixmidface titanium preformed orbital plate (pfti) (depuy synthes, west chester, pa, usa).171 patients underwent a first time repair with pfti and 24 received pfti after a previous repair.Only 47 patients had follow-up for more than 12 weeks.The following complications were reported as follows: 3 patients for the first time repair underwent removal or revision and 2 patients had reoperation.3 patients for the first time repair underwent orbital volume augmentation and 2 patients had reoperation.1 patient for the first time repair underwent strabismus surgery and 2 patients had reoperation.2 patients for the first time repair underwent upper eyelid surgery (e.G.Ptosis repair) and 2 patients had reoperation.6 patients for the first time repair underwent lower eyelid surgery (e.G.Retraction, entropion, ectropion repair) and 7 patients had reoperation.146 patients reported diplopia at presentation, which was reported as subjectively better or resolved at last follow-up in 126 patients for those who underwent first time repair.202 patients reported diplopia on presentation, which was better in 166 patients at last follow-up.29 patients had diplopia during their course and it was noted as subjectively present at last follow-up in 17 patients.3 patients had diplopia in primary gaze requiring surgery with 1 patient undergoing inferior rectus recession, i inferior oblique myectomy and 1 implant removal.1 patient had an entrapped inferior rectus muscle identified prior to the prior surgery.This is for an unknown matrixmidface titanium preformed orbital plate (pfti).This is report 1 of 2 for (b)(4).

• Brand Name: UNK - PLATES: MATRIXMIDFACE
• 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: 8905685
• MDR Text Key: 154724885
• Report Number: 2939274-2019-59877
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• 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: 07/22/2019
• 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