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

Model Number SD800.440

Device Problem Defective Device (2588)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 10/14/2020

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/ investigation.(b)(4).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

It was reported that on (b)(6) 2020, during an unknown procedure, the patient-specific implant (psi) peek implant did not fit and had to be modified intraoperatively.The procedure was complicated successfully with no surgical delay.The patient outcome was unknown.Concomitant devices reported: unknown plate (part # unknown, lot # unknown, quantity 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h6: the device was not returned.An investigation was performed by product development (psi group).The psi group reviewed the case file for this request (psi case (b)(4).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.A 3d function check device (fcd) 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 patient's ct scan information was also reviewed as part of the investigation.The acquisition parameters met the requirements of depuy synthes¿ scanning protocol (dsus-cmf-0817-0707) at the time of receipt.The slice thickness was 0.75mm, 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 10/6/2020, which is approximately 7 weeks after the scan images were taken, (b)(6) 2020.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 10/12/2020.The surgeon approved the proposed design on (b)(6) 2020.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 by product development as unconfirmed.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.H6: a device history record (dhr) review was conducted: part number: sd0800.440 lot number: 74p9390 supplier lot number: n/a manufacture date or release to warehouse date: 10/12/2020 expiration date: n/a supplier/manufacture site: brandywine no ncrs were generated during production of lot number 74p9390.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 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): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10818762
• MDR Text Key: 215603819
• Report Number: 2939274-2020-05093
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• 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: 74P9390
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2020
• Patient Sequence Number: 1
• Treatment: UNK - PLATES; UNK - SCREWS: TRAUMA; UNK - PLATES; UNK - SCREWS: TRAUMA
• Patient Outcome(s): Required Intervention