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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - PLATES: TITANIUM MESH IMPLANT PLATE, FIXATION, BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - PLATES: TITANIUM MESH IMPLANT PLATE, FIXATION, BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Eye Injury (1845); Nerve Damage (1979)
Event Type  Injury  
Manufacturer Narrative

Report is for an unk - plates: titanium mesh implant/ unknown lot. Part and lot numbers are unknown; udi 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: gebran, s. G. Et al. (2021), surgical treatment and visual outcomes of adult orbital roof fractures, plastic and reconstructive surgery, vol. Xx, pages 1-12 (usa). The purpose of this study was to examine and characterize the incidence, cause, presentation, and management of orbital roof fractures in adults who present to a single, level i, tertiary care center from 2015 to 2018. From november of 2015 to december of 2018, a total of 55 patients were treated for facial fractures of whom 8 received surgical treatment for orbital roof fractures. A total of five patients had both the superior orbital rim and orbital roof repaired. As for surgical approach, four patients had coronal incisions to repair other facial fractures, and two had a subbrow incision (one as a primary approach and one through a laceration). Four of the roof repairs were performed using a micro¿titanium mesh plate (depuy synthes, raynham, mass. ). The following complications were reported as follows: a (b)(6) year-old female patient died in-hospital. A (b)(6) year-old male patient had no light perception bilaterally. 31 patients had severe ocular complications, 19 patients had traumatic optic neurpathy, 11 patients had retrobulbar hematoma, 10 patients had macular commotion retinae. This is for an unknown synthes titanium mesh plate. This report is for one (1) unk - plates: titanium mesh implant. This is report 1 of 2 for complaint (b)(4).

 
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Brand NameUNK - PLATES: TITANIUM MESH IMPLANT
Type of DevicePLATE, 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 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12353937
MDR Text Key267672301
Report Number2939274-2021-04806
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,LITERATUR
Reporter Occupation
Type of Report Initial
Report Date 07/25/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/23/2021
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/25/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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