MAUDE Adverse Event Report: SYNTHES GMBH PSI SD800.436 PEEK IMPLANT; PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE

Catalog Number SD800.436

Device Problem Defective Device (2588)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Patient code (b)(4) used to capture injury.Without a lot number the device history records review could not be completed.Product was not returned.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 synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the patient underwent surgery with the patient specific implants in question.The two (2) psi peek implants were too big and unable to fit the patient.The surgeon freed the entire bone edge around the implant, had to saw out part of the implant and achieved suboptimal fit.There was an unspecified amount of surgical delay.There is no further information available.This report is for one (1) (b)(4) 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.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.

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.Investigation summary: the device was not received.A design investigation was conducted by product development team 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 complaint condition.No post op images or scans were provided that helps to visualize the cosmetic results.The investigation included a review of the case documentation and forms along with the surgeon report.The design was completed and verified as per the depuy synthes design instructions / process.The final implant design was approved by the surgeon with his signature on the approval letter.The re-print of the used 3d printed check devices showed a good fit of the device to the skull model.All the scan images and the timeline in the reports shows the design of implant was completely done according to the planning.Conclusion: the complaint condition cannot be confirmed for psi 160*100*40 peek (product code: sd800.436 lot:170p706) as no clear images or device was provided that can confirm complaint condition.No specific design defect or deficiency have contributed to the reported 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.Investigation summary: the device was received at west chester, cq and sent to synthes gmbh for further investigation.A design investigation was conducted by product development team based on the available product and patient information.(b)(4).Design review: during the investigation, the device design was investigated to determine the alleged complaint on the device.The design was performed with a standard 0.2mm off-set between the patient bone and implant.The general design of implant was created according to the relevant work instruction for psi designs (w-c-s030).The implant was designed with a standard thickness of 4 mm.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 (se_039100_aa).The investigation on returned devices with 3d printed check models showed that the inferior device edge to the patient skull has been extensively re-worked.The inferior device fits to the superior device as per the pre-operative planning.The inferior re-worked device shows sharp edges along the cutting edge and no deburring was performed.So the issue regarding the fit of the device cannot be confirmed.Based on the complaint description, the superior device was placed and fixed to the skull first.Based on the post-operative scan data received the superior device was not placed as per the pre-operative panning in the correct location.Therefore, the inferior device might not have fit to the patient skull.However, the complaint condition cannot be confirmed due to device being extensively re-worked.Conclusion: the complaint condition cannot be confirmed for psi 160*100*40 peek (p/n: sd800.436 & lot: 170p706).During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.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: sd800.436, lot number: 170p706, date of manufacture: 07-may-2021.No ncs found for part/lot combination.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 SD800.436 PEEK IMPLANT
• Type of Device: PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11975644
• MDR Text Key: 267297404
• Report Number: 8030965-2021-04769
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 07611819341364
• UDI-Public: (01)07611819341364
• 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
• Report Date: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD800.436
• Device Lot Number: 170P706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Date Manufacturer Received: 07/20/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention