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U.S. Department of Health and Human Services

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

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WRIGHTS LANE: SYNTHES USA PRODUCTS LLC PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Eye Injury (1845)
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 patient-specific implant - unknown lot; unknown part. Udi number is unknown. The device was removed from the patient intraoperatively. Complainant part has not been 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 the subsequent review of the following literature article: sainsbury (2017) bilateral malar reconstruction using patient-specific polyether ether ketone implants in treacher¿collins syndrome patients with absent zygomas. The journal of craniofacial surgery, volume 28(2), pages 515-517. Canada. This article is a retrospective review of case study of 3 patients, a (b)(6)-year-old boy, a (b)(6)-year-old boy, and a (b)(6)-year-old girl, all of whom had treacher¿collins syndrome (tcs) and bilaterally absent zygomata in which bilateral malar reconstruction was performed using polyether ether ketone (peek) implants. The procedure was performed first on (b)(6)-year old boy with treacher¿collins syndrome (tcs). This patient had significant mid-face hypoplasia, deformity, and absent malar bones and zygomatic arches but with the temporal process present. The implant was inserted and its position was verified clinically and via the preoperative reformatted three-dimensional (3d) computed tomography (ct) images. However, the following complications were observed in this (b)(6) year old patient: shortly after insertion of the first implant, on the left side the globe became posteromedially displaced giving an enophthalmic appearance. Additionally, slight anisocoria, giving an oblong shaped pupillary, was observed presumed secondary to temporary disruption of the efferent parasympathetic pupillary pathway. This was quickly recognized and the implant immediately explanted. The pupil regained its normal size and was minimally responsive. The implant was reduced in size and reinserted but again the globe became posteriorly displaced with severely reduced orbital volume. The implant was explanted once more. Intraoperative ophthalmological assessment noted a minimally responsive pupil. The procedure was abandoned. The (b)(6) year old patient made a full-recovery with no visual deficit. The implant was further modified where an additional 2mm relief was removed from the implant¿s orbital surface to further prevent globe compression. This modified procedure was performed 18 months later on the original patient, the (b)(6)-year-old boy, and also on remaining 2 patients, a (b)(6)-year-old girl with bilateral absent zygomatic arches and a (b)(6)-year-old boy with bilateral markedly hypoplastic zygomatic arches and only small anterior remnants without. No complications were observed. This complaint is for an unknown peek optima-lt (synthes, (b)(6)). A copy of the literature article is being submitted with this medwatch. This is report 1 of 1 for (b)(4). This complaint involves one (1) device.
 
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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
michael cote
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key7212468
MDR Text Key97989828
Report Number2939274-2018-50375
Device Sequence Number1
Product Code GXN
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2018
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 Received08/21/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/23/2018 Patient Sequence Number: 1
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