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

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.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.1.Please confirm or provide the model, lot, serial, and/or catalog number(s) of the device listed in the medical device report as applicable.A: no specific part or lot numbers were provided in the literature article.Based on the description of the product and the information in the article part is likely from the 800.4xx to 800.5xx family.2.Please provide a more complete description of this event including any relevant details surrounding the event.A: this report is for patient 3, a 9-year old boy with tcs.With significant mid-face hypoplasia, deformity, and absent malar bones and zygomatic arches but with the temporal process present.Shortly after insertion of the first implant on the left side the globe became posteromedially displaced giving an enophthalmic appearance.Slight aniscoria, was observed presumed secondary totemporary 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; however, the optic nerves were bilaterally comparable with no ischaemic stigmata.The procedure was abandoned, and the patient made a full-recovery with no visual deficit.New implants were designed based on the bony contour as well as added periorbital volume boundaries.An additional 2 mm relief was removed from the implant¿s orbital surface to further prevent globe compression.This modified procedure was performed on the original patient 18 months later.3.Please provide any evaluation of other information used by your firm to determine whether the events described in the medical device report are or are not attributable to the device.A: the information in the article was reviewed.There is no evidence of malfunction or that the implants were manufactured incorrectly.This will be reported as a serious injury (si), no malfunction.There is no allegation of a product malfunction against this device; however, because this device is dwelling in the area of the reported event it cannot be disassociated from the reported adverse event.The reported event required medical/surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.Should additional information become available, this determination should be reassessed.4.Please provide the results of any investigation, evaluation, and/or failure analysis, including underlying cause identification, relevant to the reported event.A: there is limited information we can gather from the article without knowing the details around the provided cat scan and discussion around the implant with the surgeon prior to signoff.The issue appears to be that the user needed a 2mm relief from the periorbital boundary which was not present in the initial implant.However, physical evaluation cannot be performed as the device was not returned and further patient data was not provided for review.5.Please provide a copy (or electronic location) of all current labeling for the device, including directions for use, caution statements, technical manuals, and product performance reports.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.

• Type of Device: PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE
• Manufacturer (Section D): WRIGHTS LANE: SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7212468
• MDR Text Key: 97989828
• Report Number: 2939274-2018-50375
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• 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 Received: 01/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention