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OBERDORF SYNTHES PRODUKTIONS GMBH PSI SD800.428 PEEK IMPLANT; PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE
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| Catalog Number SD800.428 |
| Device Problem
Patient-Device Incompatibility (2682)
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| Patient Problem
No Consequences Or Impact To Patient (2199)
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| Event Date 09/28/2018 |
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Event Type
malfunction
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Manufacturer Narrative
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Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).Initial reporter is synthes sales consultant.A review of the device history records has been requested.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.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 europe reports an event in (b)(6) as follows: it was reported patient underwent a cranioplasty with a synthes patient specific implant (psi) polyetheretherketone (peek) implant on (b)(6) 2018.After the procedure was completed, the surgeon stated that the peek implant did not fit exactly to the defect.No patient consequence was reported.Concomitant devices: cmf plate (part unknown, lot unknown, quantity unknown), cmf screw (part unknown, lot unknown, quantity unknown).This report is for one (1) psi peek implant.This is report 1 of 1 for (b)(4).
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Manufacturer Narrative
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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 06.04.2018.The ct scan met the requirements specified in the ct/cbct scan protocol to continue with the implant design.The skull of this case showed a frontal bilateral 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 4 mm and an offset from the psi to the defect of 1 mm.The 1 mm offset was mentioned on the approval document.Additional verification of potential interference of the psi with the skull in the ct scan (with mimics v17) was performed.No interference with the bone could be detected.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: (b)(6) 2018: the ct scan was performed; (b)(6) 2018: the case data was received by depuy synthes r&d; (b)(6) 2018: the case has been created in the trumatch cmf internal case management system; (b)(6) 2018: the design has been completed and the approval letter was sent to the sales rep.; (b)(6) 2018: surgeon approval was signed and received; 23.04.2018: the functional check device was printed and checked by an independent engineer; (b)(6) 2018: the manufacturing files were checked and released for production; (b)(6) 2018: the device was produced; (b)(6) 2018 the device was shipped; 28.09.2018: the surgery was conducted; (b)(6) 2018 the complaint pc-(b)(4).Was reported.Per the description above the psi case file was reviewed.The investigation included a review of the documentation, forms, digital model (cad) files along with the surgeon report.The design was completed and verified as per the design instructions.No design defect or deficiency potentially contributed to the complaint condition have been identified.The device was shipped on may 4, 2018.However, the surgery was recorded for sep.28, 2018.As per our ct scan protocol, the protocol states: warning: patient specific devices will be designed to fit the patient anatomy at the time of the ct or cbct scan.Changes in the patient anatomy occurring after the ct or cbct scan, as well as the use of the device after such changes, may result in a suboptimal fit of the device or implant.This non-manufacturing investigation is therefore closed by product development as non-valid 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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The implant was placed per usual with no further action taken.Procedure was completed successfully with no delay.Patient outcome was stable.
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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.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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There was no patient consequence reported.It is unknown if there was a surgical delay.Patient and procedure outcome were unknown.
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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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device history: lot part: sd800.428, lot: l879620, manufacturing site: mezzovico, release to warehouse date: 27.April 2018.The device history record shows this lot of 1 piece was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Device history batch null, device history review: the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Device was used for treatment, not diagnosis.
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