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WRIGHTS LANE SYNTHES USA PRODUCTS LLC PSI SD800.401 PEEK IMPLANT; PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE
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| Model Number SD800.401 |
| Device Problem
Defective Device (2588)
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| Patient Problem
Failure of Implant (1924)
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| Event Date 11/09/2020 |
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Event Type
Injury
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Manufacturer Narrative
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The device was received, the investigation is in progress, 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.
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Event Description
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It was reported that during a procedure on (b)(6) 2020, the psi peek implant did not fit.Instead, surgeon used a titanium plate from the midface set.Procedure was completed with a twenty (20) minute delay.Patient was stable.This report is for a psi sd800.401 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.H3, h4, h6: part sd800.401-us, lot 78p0314: date of manufacture: november 05, 2020.Place of manufacture: brandywine.No non-conformance reports (ncrs) were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint action.H3, h6: a product investigation was completed: visual inspection showed the product has several pits/scratches on the underside.The product has several large gouges along the edges.The etch is partially missing on the top and underside of the part due to heavy gouging.There was discoloration on the underside of the part.The documents that were active at the time of complaint product manufacture were reviewed.There were no nonconformance or documentation changes related to the complaint condition.Dimensional inspection showed the device was conforming.The complaint condition of "dimensional/malfunction" was not able to be confirmed.The product met the dimensional requirements of the 3d model supplied to jabil brandywine.The manufacturing investigation found that the complaint condition was not manufacturing-related for the following reasons: the 3-dimensonal model supplied by jjmd product development (pd) was identical to the 3-dimensional model used to manufacture the complaint product.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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.H3, h6: additional product development investigation was completed.The following factors were considered during the investigation to determine if any may have contributed or caused the event described in the complaint.1.Device design: 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.In this case patient ct image were provided to depuysynthes¿ planning partner (materialise) by the requesting surgeon and imported into a segmentation system to distinguish the bony elements of the mandible from soft tissue.Materialise, in consultation with the patient¿s surgeon, defined the patient¿s defect and the output of the surgical planning session is a digital file of the planned reconstruction suitable for importing into the psi design software.Upon completion of the psi design, the surgeon is provided images of the patient¿s defect along with images of how the implant fits within the defect for approval.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.On october 9, 2020, the depuy synthes chu was notified that dr.(b)(6), (b)(6) medical center was disappointed that the implant designed for his patient did not fit the patient¿s defect to his satisfaction.The complaint reported ¿it was reported that on (b)(6) 2020, the psi peek implant did not fit, it did delay the surgery long enough that they have to switch to a different implant.There was a surgical delay of twenty minutes.The patient was stable after the procedure.The procedure was successfully completed.¿ (b)(4) upon being notified of complaint the psi group reviewed the case file for this request.Review of the case file showed that prior to designing this implant the materialise team simulated the resection/defect of the orbit.This reconstructed model was used by depuysynthes as the basis of the psi design and a psi was plate was contoured to match the planned defect.Additionally, 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 surgeon approved the proposed design on (b)(6) 2020.Further review of the case file showed that this implant was shipped from depuy synthes to the sales consultant on 11/05/2020.2.Material of construction: there is no evidence that the material of construction could have caused or contributed to the complaint description of ¿the implant did not fit properly¿ and was not considered further during the investigation.3.Packaging: there is no evidence that the packaging could have caused or contributed to the complaint description of ¿the implant did not fit properly¿ and was not considered further during the investigation.4.Tolerance stack-up/mating parts/compatibility: see device design, item 1 above.5.Sterilization: there is no evidence that the sterilization process or parameters could have caused or contributed to the complaint description of ¿the implant did not fit properly¿ and was not considered further during the investigation.6.Labeling: there is no evidence that the product labeling could have caused or contributed the complaint description of ¿the implant did not fit properly¿ and was not considered further during the investigation.7.User technique: there is no evidence that the user technique could have caused or contributed the complaint description of ¿the implant did not fit properly¿ and was not considered further during the investigation.8.Manufacturing specifications: there is no evidence that manufacturing specifications could have caused or contributed to the complaint description of ¿the implant did not fit properly¿ and was not considered further during the investigation.The dhr was reviewed and no ncr¿s or nonconformances were reported.Conclusion: the investigation for the psi implant will be dispositioned as unconfirmed.Ion in conclusion, the psi implant investigated as part of this complaint passed all design and manufacturing quality checks as proscribed by the relevant work instructions for pspc contouring.The investigation revealed that the psi was designed according to the resection boundaries specified by the requestor through the materialise team and implant fit the 3d printed model.Additional follow-up with materialise should be conducted to determine if the resection or segmentation contributed to the event.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.
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