MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PSI SD800.433 PEEK IMPLANT; PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE

Model Number SD800.433

Device Problem Defective Device (2588)

Patient Problem No Code Available (3191)

Event Date 11/05/2019

Event Type  malfunction  

Manufacturer Narrative

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 as no product was received.(b)(4).The investigation could not be completed; no conclusion could be drawn at the time of filing this report.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

Device report from synthes reports an event in usa as follows: it was reported that during a craniotomy procedure on (b)(6) 2019, a patient-specific implant (psi) peek implant did not fit.The implant was to replace the entire frontal bone of the patient.When the surgeon placed it, he noticed a small discrepancy in the fit to the top of the nasal bone.The implant was shaped and the surgeon felt that it was sufficient to close.It is unknown if there was a surgical delay.Procedure and patient outcome are unknown.This report is for 1 plate, cranioplast, preformed, nonalterable.This is report 1 of 1 for (b)(4).

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h6: design review: an investigation into the device design to determine if it may have contributed or caused the event was conducted.Patient specific implants (psi) are customized devices intended to repair defects in the cranial/craniofacial skeleton.Each psi is designed for an individual patient to conform to the specific defect, patient anatomy and surgical request.Patient ct image files are provided to depuy synthes by the requesting surgeon and imported into a segmentation system (mimics) to distinguish the bony elements of the cranium from soft tissue.The result is a 3d model of the patient¿s skull showing the defect or deficiency.The 3d model is exported into cad software where, in consultation with the patient¿s surgeon, an implant is designed to match the specific geometry of the patient¿s defect or deficiency and cosmetically conform to the patient¿s anatomy.The surgeon is provided images of the patient¿s defect along with images of how the implant fits within the defect for approval.Prior to release for manufacture, models of the patient¿s cranial defect and an implant model are 3d printed.The 3d printed items are referred to as a functional check device (fcd).The fit and symmetry of the design are checked by the designer and an independent reviewer.The 3d functional check device (fcd) is then used by quality inspectors to check the fit of the manufactured implant prior to release for shipment.On february 10, 2019, the depuy synthes psi team was notified via email that the surgeon was disappointed that the implant designed for his patient did not fit the patients defect to his satisfaction.The complaint reported ¿that during a craniotomy procedure on (b)(6) 2019, a patient-specific implant (psi) peek implant did not fit.The implant was to replace the entire frontal bone of the patient.When the surgeon placed it, he noticed a small discrepancy in the fit to the top of the nasal bone.The implant was shaped and the surgeon felt that it was sufficient to close." upon being notified of complaint, the psi group reviewed the case file for this request.Review of the case file showed that the implant was reviewed and approved by the product designer, an independent reviewer, as well as the requesting surgeon according to the relevant work instructions for psi design and production.Review of the device device history record (dhr) also showed that the implant was inspected and passed the required checks necessary with no non-conformances.An fcd device was ordered and reviewed as part of the complaint investigation.Review of the model showed the implant covered the defect as designed and did not exhibit the condition described in the complaint.The patients ct scan information was also reviewed as part of the investigation.The acquisition parameters met the requirements of depuysynthes¿ scanning protocol at the time of receipt.The slice thickness was 1.0mm, there was no gantry tilt present, all images shared the same image center and the defect area was free of steps.The ct scan supplied by the account was received by depuysynthes approximately 3 months after the date the scan images were taken.The scan fell within the 4 month window for acceptance.Further review showed that this implant was shipped from depuy synthes to the account on march 6, 2019.The complaint description states that the date of the event was (b)(6) 2019; this is approximately 11 months from the date of the initial ct scan.The depuy synthes scanning protocol warns that changes in patient anatomy may occur from the time of ct scan to implantation which could result in suboptimal fit of the implant.Depuy synthes recommends that the scan be no more than 4 months old at the time of design.The patient specific implant investigated as part of this complaint passed all design and manufacturing quality checks as proscribed by the relevant work instructions for psi design and manufacture.The fcd device was reproduced and reevaluated as part of the investigation.The fcd evaluation showed that the implant fit the defect as intended and did not show any signs of not matching as described in the complaint.The investigation did reveal that implantation of the device occurred approximately 11 months after the ct scan acquisition date, changes to the patient anatomy between the date of scan and device implantation likely contributed to the complaint event.Conclusion: the complaint was not confirmed during investigation.There were no issues during the manufacture of this product that would contribute to this complaint condition.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.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.

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: a1: patient id # (b)(6).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.

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.H3, h6: investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.Device history lot: part number: sd800.433.Lot number: h851316.Date of manufacture: 03/06/2019.Place of manufacture: brandywine.Part expiration date: n/a.List of non-conformances: none.Device history review: no ncrs (non-conformances) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint action.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.

• Brand Name: PSI SD800.433 PEEK IMPLANT
• 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: 9343742
• MDR Text Key: 179226438
• Report Number: 2939274-2019-62292
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 10887587065069
• UDI-Public: (01)10887587065069
• Combination Product (y/n): N
• PMA/PMN Number: K053199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SD800.433
• Device Catalogue Number: SD800.433
• Device Lot Number: H851316
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1