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WRIGHTS LANE SYNTHES USA PRODUCTS LLC PSI SD800.541 PEEK IMPLANT; PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE
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| Model Number SD800.541 |
| Device Problems
Manufacturing, Packaging or Shipping Problem (2975); Appropriate Term/Code Not Available (3191)
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| Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.
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Event Description
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It was reported that on an unknown date, a surgeon was not happy with the fit of a peek implant.Procedure outcome was unknown.Patient involvement was unknown.This complaint involves one (1) device psi sd800.541 peek implant.This is 1 of 1 for report (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device history: part number: sd800.541.Lot number: 17p4529.Part manufacture date: 09/13/2019.Manufacturing location: brandywine.Part expiration date: n/a.Nonconformance noted: n/a.Dhr record review: a review of the device history record of this lot revealed no complaint-related anomalies.The device history record shows that the psi peek implant was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.The product lot met all manufacturing, inspection, laser etch, and packaging criteria at the time of release with no issues documented during manufacture that would contribute to this complaint condition.The implant met all manufacturing, inspection, laser etch, and packaging criteria at the time of release with no issues documented during 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.Patient identifier: additional case 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.
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Event Description
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The surgeon completed the surgery and plate had slight gap next to bone.There was no surgical delay.There will be no revision surgery.There was no injury to the patient.
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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).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 (b)(6) 2019, 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 an unknown date, a surgeon was not happy with the fit of an implant.The surgeon continued with the procedure; the plate had a slight gap next to the bone.There was no surgical delay.There will be no revision surgery.There was no injury to the patient.¿ (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.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 (b)(6) 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 (b)(6) 2019, which was approximately 8 days after the date the scan images were taken, (b)(6) 2019.The scan fell within the 4 month window for acceptance.Further review of the case file showed that this implant was shipped from depuy synthes to the account on (b)(6) 2019.The approval report which was provide to the surgeon for review offered 2 design options.The first design showed a device which covered the entire defect.The second design showed an implant with the temporal area removed to allow for less dissection of the temporalis muscle.The surgeon selected the full coverage design on (b)(6) 2019.The complaint description reports that the surgeon continued with the procedure, the plate had a slight gap next to the bone.The event report goes on to state that there was no surgical delay and there was no injury to the patient.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 patient¿s 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.It should also be noted that this implant was shipped with a 3d printed model of the patients defect along with a model of the implant for patient consultation or as a reference in surgery.There is no indication in the event description that the model exhibited the same condition seen in the surgery.The investigation found that the surgeon selected the full coverage option instead of having the temporalis portion removed to allow for less soft tissue dissection.There was not enough information in the report to determine if temporalis interference contributed to the event.There was no surgical delay, no injury to the patient and no revision surgery was planned.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: part number: sd800.541.Lot number: 17p4529.Part manufacture date: 09/13/2019.Manufacturing location: brandywine.Part expiration date: n/a.Nonconformance noted: n/a.Dhr record review: a review of the device history record of this lot revealed no complaint-related anomalies.The device history record shows that the psi peek implant was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.The product lot met all manufacturing, inspection, laser etch, and packaging criteria at the time of release with no issues documented during manufacture that would contribute to this complaint condition.Device history review: the implant met all manufacturing, inspection, laser etch, and packaging criteria at the time of release with no issues documented during 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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