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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - PEEK IMPLANT PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - PEEK IMPLANT PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Post Operative Wound Infection (2446)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown peek 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: lee jh, kaban lb, yaremchuk mj (2018), refining post¿orthognathic surgery facial contour with computer-designed/computer- manufactured alloplastic implants, plastic and reconstructive surgery, volume 142, number 3, pages 747-755, (usa). This retrospective review describes the use of implants produced by means of computer aided design/computer-aided manufacturing to refine facial contour and balance after orthognathic surgery. From 2009 to 2016, 21 patients who underwent midface and mandible contour augmentation surgery were included in the study. There were 9 women and 12 men with a mean age of 28 years (range, 18 to 50 years). Three-dimensional images were reconstructed from computed tomographic scans in patients unhappy with their appearances after le fort i advancement and/or bilateral sagittal split osteotomies. The data from these scans were used to produce alloplastic implants. Three materials¿silicone rubber, porous polyethylene, and polyetheretherketone (unknown synthes peek) ¿were used for implants produced by means of computer-aided design/computer aided manufacturing. A total of 6 patients were implanted with the unknown synthes peek, 9 received a competitor¿s solid silicone implants and 6 received a competitor¿s porous polyethylene implants. The implants were surgically placed through intraoral and submental incisions and fixed using titanium screws. The wounds are closed in layers after a suction drain is placed, which exits in the postauricular area. The drain is usually removed the morning after surgery. The average follow-up was 2 years (range, 1 to 7 years). The authors did not specify which patients received the synthes device. Thus, complications will be reported as follows: 1 patient had infection requiring removal of the mandible implants, which were not replaced. 1 patient who had 2 le fort i osteotomies developed a synkinesis after midface implant placement. This report is for the unknown synthes peek and unknown synthes titanium screws. This report is for one (1) unk - peek implant. This is report 2 of 2 for (b)(4).
 
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Brand NameUNK - PEEK IMPLANT
Type of DevicePLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE
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 Key11609123
MDR Text Key244145183
Report Number2939274-2021-01666
Device Sequence Number1
Product Code GXN
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 03/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received03/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/02/2021 Patient Sequence Number: 1
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