MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PSI SD800.440 PEEK IMPLANT; PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE

Model Number SD800.440

Device Problem Defective Device (2588)

Patient Problem No Code Available (3191)

Event Date 06/05/2019

Event Type  Injury  

Manufacturer Narrative

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.(b)(4).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 that on (b)(6) 2019, the patient underwent a cranioplasty with the placement of a personalized patient-specific implant (psi) peek implant.Verification of the implant code was made with the patient's identification, intra-surgically it is evident that the personalized implant does not adapt correctly to the bone defect.In the posterior temporal part, it is too prominent and did not match the concavities, in the upper front part it was elevated.The surgeon performs release and greater exposure of the bone to try to adapt the implant but, at the time of union in the front part rose in the temporal and visceral parts.The specialist says that the implant feels too thick comparing it with other implants that it had placed.The surgeon states that the edges of the implant must be milled and reshaped, approximately 4 mm of each side was cut.The peek implant achieved better adaptation of the implant and is fixed with 7 plates and their respective screws.The procedure was successfully completed with one hundred fifty (150) minutes of surgical delay.There was no patient consequence.Concomitant device/s reported: unknown plate (part # unknown, lot # unknown, quantity of 1), unknown screws (part # unknown, lot # unknown, quantity unknown).This report is for one (1) psi sd800.440 peek implant.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.H3, h4, h6: part: sd800.440, lot: 4l68685, manufacturing site: mezzovico, release to warehouse date: may 14, 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 shared with depuy synthes r&d on april 17, 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 defect on the patient¿s right 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 0.2 mm.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.Images 1 and 2 indicate a minor (up to 0.81mm) area 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.The thickness in these areas may have contributed to the data loss during file conversion which can be shown in images 1 and 2.These considerations are in-line with the 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, the signed approval document highlighted several residual bony elements (free-floating, bone fragments) that were indicated to be removed by the surgeon during surgery.It is not definitive if this removal of residual bone took place or not.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.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.The design review indicates a potential contact area between the bone and the implant, the potential contact with residual bone, as well as the bony anatomy with regards to density and thickness may have contributed to the complaint condition.However, this potential minor interference is adequately addressed by the devices instructions for use.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.

• Brand Name: PSI SD800.440 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: 8757685
• MDR Text Key: 149931272
• Report Number: 8030965-2019-65969
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 10887587065113
• UDI-Public: (01)10887587065113
• 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
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SD800.440
• Device Catalogue Number: SD800.440
• Device Lot Number: 4L68685
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/05/2019
• Initial Date FDA Received: 07/03/2019
• Supplement Dates Manufacturer Received: 06/30/2020
• Supplement Dates FDA Received: 06/30/2020
• Patient Sequence Number: 1
• Treatment: UNK - PLATES: CMF; UNK - SCREWS: CMF; UNK - PLATES: CMF; UNK - SCREWS: CMF
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR
• Patient Weight: 75