MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - SYNPOR IMPLANTS; BONE PLATE

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

Patient Problems Visual Impairment (2138); No Code Available (3191)

Event Date 11/01/2017

Event Type  Injury  

Manufacturer Narrative

Exact date of event is unknown; november 01, 2017 is the date the literature article was published.This report is for an unknown synthes 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.(b)(4).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: firriolo, j.M.Et al (2017), pediatric orbital floor fractures: clinical and radiological predictors of tissue entrapment and the effect of operative timing on ocular outcomes, the journal of craniofacial surgery, vol.28 (8), pages 1966-1971 (usa).The aim of this retrospective study is to determine clinical and radiological predictors of tissue entrapment, to explore the outcomes of tissue entrapment and establish how these are influenced by the timing of surgical management.Between october 2007 to october 2015, a total of 152 patients (122 males and 30 females) with a mean age of 12.2±4.2 years were included in the study.Only 12 patients with tissue entrapment were treated with synpor polyethylene-titanium mesh (depuy synthes, west chester, pa) or a competitor¿s device.Patients with tissue entrapment underwent follow-up for a mean of 5.2 months.The following complications were reported as follows: 7 patients had postoperative diplopia, in which 3 experienced resolution of this symptoms.3 patients had extraocular movement restriction.This report is for an unknown synthes synpor implant.This is report 1 of 2 for (b)(4).

• Brand Name: UNK - SYNPOR IMPLANTS
• Type of Device: BONE PLATE
• 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: 8907423
• MDR Text Key: 154788365
• Report Number: 2939274-2019-59905
• Device Sequence Number: 1
• Product Code: JEY
• 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