MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PSI SD800.427 PEEK IMPLANT; PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE

Model Number SD800.427

Device Problem Fitting Problem (2183)

Patient Problems Foreign Body Reaction (1868); No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 11/09/2017

Event Type  Injury  

Manufacturer Narrative

Patient date of birth and weight were not provided for reporting.Device was not explanted.Device is not expected to be returned for manufacturer review/investigation.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review is pending completion.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

It was reported that on (b)(6) 2017, patient underwent a cranioplasty surgery.During the surgery, the patient specific custom-made peek spacer did not fit to the patient's anatomy as needed.Surgeon proceeded to complete the surgery and the patient was reported to be in stable condition.There was no reported surgical delay.This report is for one (1) psi sd800.427 peek implant.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Upon receipt of the additional complaint information, the reporting determination has changed from product problem only to serious injury and product problem.Patient code (b)(4) used to capture additional medical/surgical intervention required.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

The peek implant was made but did not fit so they cut one in the operating room (or).The patient has an allergy to nickel that the facility was not aware of prior to the procedure.

Manufacturer Narrative

Device history records review was completed for part# sd800.427, lot# h49765.Manufacturing location: (b)(4), manufacturing date: nov 03, 2017.No non-conformance reports were generated during production.Review of the device history records 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.

Manufacturer Narrative

The device was not returned.The investigation was performed by product development (pd).Design review: 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.The 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.Also, prior to release for manufacture, models of the patient¿s cranial defect and an implant model are 3d printed.The 3d printed items are referred to as a functional check device (fcd).The fit and symmetry of the design are checked by the designer and an independent reviewer.The 3d functional check device (fcd) is then used by quality inspectors to check the fit of the manufactured implant prior to release for shipment.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 november 09, 2017, the depuy synthes complaint handling unit (chu) was notified by the surgeon that the implant designed for his patient did not fit the patient¿s defect to his satisfaction.This event involved only one device.This was confirmed by the chu and was also confirmed by a search of case file for this patient name and/or surgeon/facility.Upon being notified of complaint the psi group reviewed the case file for this request.Review of the 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.Review of the device dhr also showed that the implant was inspected and passed the required checks necessary with no non-conformances.An fcd device was ordered and reviewed as part of the complaint investigation.Review of the model showed the implant covered the defect as designed and did not exhibit the condition described in the complaint.The patients ct scan information was also reviewed as part of the investigation.The acquisition parameters met the requirements of depuysynthes¿ scanning protocol at the time of receipt.The slice thickness was 0.625mm, 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 depuysynthes on (b)(6) 2017, which was approximately 1 week after the date the scan images were taken, (b)(6) 2017.The scan fell within the 4 month window for acceptance.Further review of the case file showed that this implant was shipped from depuy synthes to the sales consultant on 11/03/2017.The surgeon approved the proposed design on (b)(6) 2017.The complaint description reports that the surgeon trimmed the implant for a more optimal fit.This is inline with the instructions for use for modification of the implant.The event report states that there was no surgical delay and that the implant was used after trimming and the patient left the or.The patient specific implant investigated as part of this complaint passed all design and manufacturing quality checks as proscribed by the relevant work instruction for psi design and manufacture.The investigation showed that the psi implant fit the patient¿s bony defect, met the thickness criteria at inspection and the design was approved by the operating surgeon prior to implantation; sight differences in the surgical dissection or resection are expected and the surgeon successfully modified the device without surgical delay.This is supported by the event description that the surgical modification of the implant resulted in a satisfactory fit and the patient left the or without further incident.The investigation will be dispositioned as unconfirmed.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 SD800.427 PEEK IMPLANT
• Type of Device: PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 7100265
• MDR Text Key: 95077820
• Report Number: 2939274-2017-50188
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 10887587065007
• UDI-Public: (01)10887587065007(10)H497659
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SD800.427
• Device Catalogue Number: SD800.427
• Device Lot Number: H497659
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2020
• Date Device Manufactured: 11/03/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR