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OBERDORF SYNTHES PRODUKTIONS GMBH PSI SD800.433 PEEK IMPLANT; PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE
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| Catalog Number SD800.433 |
| Device Problem
Use of Device Problem (1670)
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| Patient Problems
Skin Erosion (2075); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Product complaint #: (b)(4).This report is for an unknown psi implants: trauma/unknown lot number.Without the specific part number, the udi number and 510k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthe rep.(b)(4).Without a lot number, the device history records review could not be completed 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.
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Event Description
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Device report from synthes reports an event in (b)(6) as follows: it was reported that an adverse incident with a psi, lot and reference is unknown.The case number of the psi is: (b)(4).A peek plasty psi with 3 mini plates and 6 screws was implanted (we don't know if the screws are from another commercial house).On (b)(6) 2012 the patient presented a small asymmetry in the plasty psi, as well as in one of the screws of the titanium lower plate that had been released.The same cranioplasty is replaced again, but 4 months later another of the screws is released with the result of another intervention and has an infection altering the bone and osteosynthesis material.On (b)(6) 2012 cranial ct scan is performed again because plasty psi mobility is objective.On (b)(6) 2012 is re-operated by placing the same plasty psi and using a greater number of plates to ensure anchoring.On (b)(6) 2014, a skin lesion occurs due to a continuous rubbing by a screw and is intervened again and with the same plasty psi.The plasty psi does not fit 100% correctly, but they decide not to change it.On (b)(6) 2018 placement of 6 new plates.The patient experience a post-op device malfunction, adverse event, such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing, not well fixation.In addition, the patient require revision surgery, unknown if the device was explanted.Patient consequence were a clinical outcome experienced by the patient (infection, inflammation, infection, pain, and re-interventions, x-rays, additional procedures, prescriptions, otc, revision was required.Concomitant device reported: unknown screws (part #: unknown, lot #: unknown, quantity #: unknown), unknown plates (part #: unknown, lot #: unknown, quantity #: unknown).This complaint involves three (3) device.This report is for one (1) unk - psi implants.This report is 1 of 3 for (b)(4).
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Manufacturer Narrative
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Product complaint # (b)(4).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.Initial reporters state: (b)(6).Investigation summary product was not returned.Based on the information available, it has been determined that no corrective and preventive 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 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.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: sd800.433, lot: 3816404, manufacturing site: mezzovico, release to warehouse date: 23.May.2011.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.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.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: b5: additional information.H6: the device was not returned.The investigation was performed by product development (pd).Design review: an investigation was conducted into the device design to determine if the design contributed or caused the event.The ct scan information of this case was shared with depuy synthes r&d on the 16.02.2011 (see ¿timing¿).The skull of this case showed a frontal defect.The implant in scope of this investigation is positioned on the right patient side.The design for the implant was created according to the relevant work instruction for psi design.The implant was designed with a standard thickness of 3 mm.Review of the case file ¿patient specific implant design review checklist¿ for this implant showed that the implant was reviewed and approved by an independent reviewer according to the relevant work instruction for psi design.Timing: 16.02.2011: the ct scan was performed.11.04.2011: the case data was received by depuy synthes r&d (case id (b)(4)).11.04.2011: the case has been created in the trumatch cmf internal case management system (with the id (b)(4)).14.04.2011: the design has been completed and the approval letter was sent to the sales rep.27.04.2011: surgeon approval was signed and received.23.05.2011: the manufacturing files were checked and released for production.23.05.2011: the device was produced.24.05.2011: the device was shipped.Not known: initial surgery was conducted.22.11.2019: the complaint (b)(4) was reported.22.11.2019: the complaint (b)(4) was reported.Per the description the psi case file was reviewed.The investigation included a review of the documentation and forms along with the surgeon report.The design was completed and verified as per the design instructions.The not 100% fit of the device described in complaint (b)(4) captures the (b)(6) 2014 which is more than three years after the initial implantation cannot be explained by pd with the provided information.No design defect or deficiency potentially contributed to the reported complaint conditions have been identified.This non-manufacturing investigation is therefore closed by product development as undetermined regarding a design related root cause.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.
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Event Description
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This report captures the (b)(6) 2014 event regarding a skin lesion that occurred due to a continuous rubbing by a screw and was intervened again and with the same plasty psi.The plasty psi does not fit 100% correctly, but they decide not to change it.Related complaint (b)(4) captures the (b)(6) 2012 event.The patient presented a small asymmetry in the plasty psi, as well as in one of the screws of the titanium lower plate that had been released.The same cranioplasty was replaced again.Related complaint (b)(4) captures the unknown post-op event involving the same cranioplasty that was replaced again, but 4 months later another of the screws was released with the result of another intervention and had an infection altering the bone and osteosynthesis material.Related complaint (b)(4) captures the events for (b)(6) 2012 regarding a cranial ct scan that was performed again because plasty psi mobility was objective.And (b)(6) 2012 regarding a re-operation by placing the same plasty psi and using a greater number of plates to ensure anchoring.Related complaints (b)(4) captures nine (9) devices, while (b)(4) captures ten (10) devices.
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Search Alerts/Recalls
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