MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PSI SD800.434 PEEK IMPLANT; PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE

Catalog Number SD800.434

Device Problem Defective Component (2292)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 10/10/2019

Event Type  Injury  

Manufacturer Narrative

Pma/510k: device is not distributed in the united states but is similar to device marketed in the usa.Investigation summary: 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 lot: part: sd800.434, lot: 6l04873, manufacturing site: (b)(4), release to warehouse date: sept 06, 2019.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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that during a skull repair surgery, doctor noted the peek implant did not completely match the patient's skull defect, the size did not match.Some margins: there was gap with the defect skull, the surgeon needed to extract autogenous bone to supplement.Some margins: larger than the defect skull and the surgeon needed to grind down.The surgery delayed about 2 hours.The patient is stable now.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

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.H6: code 3191 used to capture surgical intervention.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.

Manufacturer Narrative

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: sd800.434, lot: 6l04873, manufacturing site: mezzovico, release to warehouse date: 06 sept 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 provided to depuy synthes r&d on 09-jul-2019.The ct scan met the requirements specified in the ct/cbct scan protocol to continue with the implant design.The cranium in this case showed a defect on the left side of the patient.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 0.2 mm.The approval document was created with a disclaimer for adolescent patients calling out the following information: ¿attention, be aware that an adolescent patient will grow whereas the psi will not! appropriate follow-up is therefore essential.¿ upon surgeon approval, a functional check device was 3d printed and checked by an independent designer who reviewed the physical verification model against the case file and found the device to be acceptable and approved the design.The 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 (w-c-s030 rev.1).Upon receipt of this complaint information, a further retrospective review of this case was performed, using mimics (v17) to review the design files (stl format) in conjunction with the original dicom (ct) data set.This additional verification revealed potential contact points of the psi with the skull in the ct scan.The images 1, 3, 4 and 5 (reference pi attachment), indicate minor (up to 1.8mm) locations which could have contributed to the received surgeon feedback.Although not a definitive cause of the complaint, this may have contributed to the intra-operative issue.It must also be mentioned that the age of the patient (20 months) potentially contributed to the issue based on several factors including: bone density and ct scan segmentation (vs.An adult), the shape of the skull and the perimeter of the skull defect prior to reconstruction may have changed due to the patient growth rate at that age (the duration of time from ct scan to implantation is at 25% of the patients¿ lifespan), and the boney thickness.The thickness alone may have contributed to the data loss during file conversion which can be compared between image 1 and 2.The bone dynamics of patients at this age is described in several clinical articles (see pi attachment for article reference).These considerations are in-line with the current patient specific implant instructions for use, ¿before fixing the patient specific cranial/craniofacial implant, bone resection may be performed and the bone interface may be cleaned according to the images for approval, previously defined by the surgeon¿ and ¿the edges of the peek device may be tapered/feathered by the surgeon prior to implanting the device to overlap the native bone.¿ additionally, this was instructed in the surgeon approval document.Conclusion the complaint was not confirmed during investigation: a potential, minimal interference issue was identified during investigation; however, as the reported condition did not detail the specific areas of interference, the reported condition could not be confirmed.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.

Manufacturer Narrative

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.D10: complainant part is not expected to be returned for manufacturer review/investigation.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.

Manufacturer Narrative

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.H11: corrected data: g4: awareness date reported on follow up 2 report as december 20, 2019 but should have been march 30, 2020.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.

• Brand Name: PSI SD800.434 PEEK IMPLANT
• Type of Device: PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9587457
• MDR Text Key: 189197125
• Report Number: 8030965-2020-00358
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 07611819341340
• UDI-Public: (01)07611819341340
• Combination Product (y/n): N
• PMA/PMN Number: K053199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD800.434
• Device Lot Number: 6L04873
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/13/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 2 YR