MAUDE Adverse Event Report: SYNTHES GMBH PSI SD800.402 PEEK IMPLANT; PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE

Catalog Number SD800.402

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

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.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 (b)(6) reports an event as follows: it was reported that patient underwent bimaxillary reconversion osteotomy on (b)(6) 2020 with patient-individual guides and implants: maxilla - guide and 3d printed implants and lower jaw angle augmentates left and right from peek.During the procedure, the peek implant was modified with a milling cutter in the spacer area.However, the fit accuracy was not 100% optimal, since the augmentate was still not in line with the bone on the ascending branch.Patient has been noticing this gap and the augmentate should be removed and replaced.The new design has already been created but has not yet been released for production by the surgeon.Surgery date is not yet known.This report is for a psi sd800.402 peek implant.This is report 2 of 2 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: updated data: h4, h6.Investigation summary the device was not received.A product development investigation was conducted based on the available product and patient information.Design review an investigation was conducted into the device design to determine if the design contributed or caused the event of the described fitting issue.This specific case involved a pre-operative planning between a materialise clinical engineer and the case surgeon to determine the plan, including the bilateral sagittal split osteotomies (bsso).Depuy synthes, communicate for bsso cases with patient specific implants (psi) devices on the case specific case approval letter (reference pi attachment, image 1).Pi attachment images 2 and 3 represent implant design images taken from the case approval letter show the computer aided software planned bone alignment and location as planned by materialise and the surgeon together with the psi devices in place.The designs for the two psi implants was created according to the relevant work instruction for psi design (b)(4).The review of the case files ¿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.The case specific 3d model review for the design of the two psi devices did not produce any interface fit with the scanned bone model segments provided by materialise.There is no evidence that the material of construction could have caused or contributed to the complaint description.There is no evidence that the packaging could have caused or contributed to the complaint description.There were no issues related to tolerance stack-up/ mating parts / compatibility.Per the investigation description above 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 depuy synthes design instructions.The surgeon approved with his signature on the approval letter the design of the devices.This complaint investigation did not identify a design defect or deficiency based on the data available which potentially contributed to the reported complaint conditions.Therefore, this non-manufacturing investigation is closed by product development as not-valid regarding a design related root cause.Conclusion the complaint was not confirmed during investigation.There were no issues during the manufacture of the device that would contribute to the 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 product code: sd800.402 lot number: 43p8338.Manufacturing site: (b)(6).Release to warehouse date:(b)(6) 2020.A manufacturing record evaluation was performed for the not sterile 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.

• Brand Name: PSI SD800.402 PEEK IMPLANT
• Type of Device: PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11116788
• MDR Text Key: 228182825
• Report Number: 8030965-2021-00043
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 07611819337749
• UDI-Public: (01)07611819337749
• 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: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD800.402
• Device Lot Number: 43P8338
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/27/2021
• Patient Sequence Number: 1
• Treatment: PSI 60*20*40 PEEK.; UNK - PLATES.; UNK - PSI INSTRUMENTS.
• Patient Outcome(s): Required Intervention