MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PSI SD800.440 PEEK IMPLANT; PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

Catalog Number SD800.440

Device Problem Defective Device (2588)

Patient Problem Failure of Implant (1924)

Event Date 12/07/2020

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 that the patient specific implant design did not fit the head of the patient properly and the surgery was aborted.This report is for one (1) psi sd800.440 peek implant.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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: investigation summary: the device was not returned.An investigation was performed by product development (psi group).Design review: examination of the received images showed that the anterior portion left implant was heavily modified.While minor modifications to achieve an optimal fit can be performed and are within the instructions for use, the extensive modification shown in the images would not be expected.An investigation into the device design to determine if it may have contributed or caused the event was conducted.Patient specific implants are customized devices intended to repair defects in the cranial/craniofacial skeleton.Each psi is designed for an individual patient to conform to the specific defect, patient anatomy and surgical request.Patient ct image files are provided to depuy synthes by the requesting surgeon and imported into a segmentation system to distinguish the bony elements of the cranium from soft tissue.The result is a 3d model of the patient¿s skull showing the defect or deficiency.This 3d model is exported into cad software where, in consultation with the patient¿s surgeon, an implant is designed to match the specific geometry of the patient¿s defect or deficiency and cosmetically conform to the patient¿s anatomy.The surgeon is provided images of the patient¿s defect along with images of how the implant fits within the defect for approval.Prior to release for manufacture, the fit and symmetry of the design are checked on the cad model by the designer and an independent reviewer.The 3d cad model is then used by manufacturing to manufacture the device.Quality inspectors utilize the same cad model to optically compare the manufactured device to the cad model released by the design team.This process is called blue light scanning.Review of the case file for this implant showed that the implant was reviewed and approved by the product designer, an independent reviewer and the requesting surgeon according to the relevant work instructions for psi design and production.Review of the device dhr also showed that the implant was inspected and passed the required checks necessary for shipment to the customer.On december 7, 2020, the depuy synthes chu and the trumatch team were notified that a canadian surgeon, dr.(b)(6) , was alarmed that the implant designed for the patient did not fit the patient¿s defect.The complaint reported that during the procedure, ¿the patient specific implant design did not fit the head of the patient properly and we had to abort surgery.¿ upon being notified of complaint the psi group preliminarily reviewed the case file for this patient ((b)(4)) and scheduled a call with the surgeon the same day.During the call dr.(b)(6) indicated that the left implant fit the defect well at the posterior margin but seemed to grossly extend beyond the anterior margin.He described the implant as extending almost to the nasal bone.This condition is not seen in the images sent to the surgeon for review.It was initially suspected that there was a scaling issue with the ct scan causing the implant to be designed to an inaccurate model.During the call the surgeon requested that the trumatch team produce another set of implants for this patient.In order to help investigate the initial suspicion and to ensure that the replacement implants did not exhibit the same condition a new ct scan was ordered and provided to depuy synthes.A new case was created to produce the replacement implants.Review of the initial case file showed that the implant was reviewed and approved by the product designer, an independent reviewer as well as the requesting surgeon according to the relevant work instructions for psi design and production.The cad file used for design, manufacturing and inspection were also reviewed as part of the complaint investigation.The review showed that implant fit within defect without interference.The implant covered deficit, the shape matched the patient¿s anatomy and there was a smooth transition between the implant and the native bone.There was no evidence of the condition described in the complaint.The patients initial ct scan information was also reviewed as part of the investigation.The acquisition parameters met the requirements of depuy synthes¿ scanning protocol at the time of receipt.The slice thickness was 0.6mm, there was no gantry tilt present, all images shared the same image center and the defect area was free of steps.The ct scan supplied by the account was received by depuy synthes on 10/30/2020.The scan fell within the 4-month window for acceptance.It should be noted that there were areas of resorbed bone throughout the defect.These areas were noted on the images for approval.The surgeon gave approval to proceed on (b)(6) 2020.The ct scan used for the replacement implants was received by depuy synthes on (b)(6) 2020.The resulting defect model generated from the new scan was compared to the original defect and no scaling issues or significant differences were observed.Models of the patient¿s skull generated from each ct of the scans were also 3d printed.These models were reviewed, and no significant differences were observed.New implant designs were generated using new data in the normal manner.3d printed models of the both the original and replacement devices were generated.These device models were test fit with each of the skull models.Review showed that both the original and replacement designs fit each of the skull models and did not present the condition described in the event.New approval images were sent to the surgeon for review.In addition to the 2d images, each of the 3d printed models described above were also sent.The surgeon reviewed the new proposal along with the 3d models and approved the replacement design on (b)(6) 2020.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: part number: sd0800.440.Lot number: 79p8267.Supplier lot number: n/a.Manufacture date or release to warehouse date: 11/20/2020.Expiration date: n/a.Supplier/manufacture site: brandywine.No ncrs were generated during production of lot number 79p8267.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Device history review: review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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, NON-ALTERABLE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11116364
• MDR Text Key: 225048737
• Report Number: 2939274-2021-00018
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• PMA/PMN Number: K033868
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2020

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: SD800.440
• Device Lot Number: 79P8267
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention