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WRIGHTS LANE SYNTHES USA PRODUCTS LLC PSI SD800.426 PEEK IMPLANT; PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE
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| Model Number SD800.426 |
| Device Problem
Device Operates Differently Than Expected (2913)
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| Patient Problems
Injury (2348); No Code Available (3191)
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| Event Date 05/16/2018 |
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Event Type
Injury
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Manufacturer Narrative
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Patient id also reported as (b)(6).Age, weight: this information is unknown.Explanted date: device has not been explanted.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history records review has been requested.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.
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Event Description
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It was reported that during a craniotomy on (b)(6) 2018, a patient specific (psi) polyetheretherketone (peek) implant did not fit the defect properly along the posterior edge.The implant was off by about 1mm.The surgeon burred down the bone to make the implant fit.There was a surgical delay of approximately 15 minutes.Procedure was successfully completed.Patient outcome was stable.This report is for a psi (b)(4) peek implant.This is report 1 of 1 for (b)(4).
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Manufacturer Narrative
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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.Part sd800-426, lot h643399: part manufacture date: may 14, 2018.Manufacture location: brandywine.Review of device history record (dhr) revealed no complaint related anomalies.The dhr shows this peek implant was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to the complaint condition.Dhr review of raw material revealed this lot met all specification with no nonconformities noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.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.
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Manufacturer Narrative
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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.H10 additional narrative: h3, h6: investigation summary.The device was not returned.The investigation was performed by product development (pd).Refer to attachment ¿complaint investigation memo (b)(4)¿.Design review: an investigation into the device design to determine if it may have contributed or caused the event was conducted.Patient specific implants 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 depuysynthes by the requesting surgeon and imported into a segmentation system 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 (see attached surgeon approval letter).Also, 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.Review of the case file for this implant showed that the implant was reviewed and approved by the product designer, an independent reviewer and the requesting surgeon according to the relevant work instructions for psi design and production.Review of the device dhr also showed that the implant was inspected and passed the required checks necessary for shipment to the customer.On may 17, 2019, the depuy synthes trumatch team was notified that dr.(b)(6) hospital, was disappointed that the implant designed for his patient did not fit the patient¿s defect to his satisfaction.The complaint reported ¿the peek implant we produced for dr.(b)(6) was not an exact fit.¿the posterior edge of the implant extended approximately 1mm too far.This required dr.(b)(6) to burr down skull bone (in the area indicated in the attached image) so the implant would fit, which added to the case time¿ patient outcome was good.(b)(4)).Upon being notified of complaint the psi group reviewed the case file for this request (psi case (b)(4) 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 dhr also showed that the implant was inspected and passed the required checks necessary with no non-conformances.(see attached dhr record).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.(see attached photos) the patients ct scan information was also reviewed as part of the investigation.The acquisition parameters met the requirements of depuysynthes¿ scanning protocol (b)(4)) 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 on 05/09/2018, which was approximately which was the same day the scan images were taken.The scan fell within the 4-month window for acceptance.(see attached 103286202).It should also be noted that the ct images contained a metallic mesh from a previous surgery.This mesh was segmented from the bone in order to generate a cad model which was used as the basis of the design.This mesh would be dissected by the surgeon prior to implanting the psi device.Further review of the case file showed that this implant was shipped from depuy synthes to the account on (b)(6) 2018.The approval report which was provide to the surgeon for review showed the preoperative condition with the metallic mesh in place along with an image of the cranial defect with the mesh virtually removed.The report also show an images of the proposed implant design to cover the virtually dissected defect.The patient specific implant investigated as part of this complaint passed all design and manufacturing quality checks as proscribed by the relevant work instruction for psi design and manufacture.The investigation showed that the psi implant fit the virtually dissected bony defect, did not violate the inner table of the bone, met the thickness criteria at inspection and the design was approved by the operating surgeon prior to implantation; therefore there is no evidence that the design contributed to the complaint.The investigation found that the reported event most likely occurred due to differences in the virtual removal of the metallic mesh as compared to how the surgeon dissected the mesh in-situ.Metallic objects can obscure underlying bony details due to image scatter.Small errors in these regions would not be unexpected.This is supported by the event description that a surgical modification of approximately 1mm of bone posteriorly resulted in a satisfactory fit.The investigation will be dispositioned as unconfirmed.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 history lot: product complaint #: (b)(4).Product investigation: (b)(4).Part number: sd800-426.Lot number: h643399.Part manufacture date: 5-14-2018.Manufacture location: brandywine.Part expiration date: na.Nonconformance noted: na.Dhr record review: review of dhr revealed no complaint related anomalies.The dhr shows this peek implant was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to the complaint condition.Dhr review of raw material revealed this lot met all specification with no nonconformities noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.Device history review: this lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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.
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Manufacturer Narrative
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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.H10 additional narrative: h6.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.
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