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 Defective Device (2588)

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

Event Date 09/16/2020

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, the patient underwent a cranioplasty.During the procedure, the surgeon was not satisfied with the fit of the peek implant received.The peek implant had to be modified intraoperatively.The doctor burred both the boney prominence and the peek implant.Not much burring was needed to get a good fit.The procedure was successfully completed with no surgical delay.The patient's status was reported as great.Concomitant device reported: unknown screw (part#: unknown, lot#: unknown, quantity: unknown).This report is for one (1) psi sd800.427 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.The device was not returned.An investigation was performed by product development (psi group).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.It should also be noted that the ct images contained a metallic mesh from a previous surgery.This mesh was segmented from the bone in order to generate a cad model which was used as the basis of the design.This mesh would be dissected by the surgeon prior to implanting the psi device.Further review of the case file showed that this implant was shipped from depuy synthes to the account on 08/26/2020.The approval report which was provide to the surgeon for review showed the preoperative condition with the metallic mesh in place along with an image of the cranial defect with the mesh virtually removed.The report also shows images of the proposed implant design to cover the virtually dissected defect.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 virtually dissected bony defect, did not violate the inner table of the bone, met the thickness criteria at inspection and the design was approved by the operating surgeon prior to implantation; therefore there is no evidence that the design contributed to the complaint.The investigation found that the reported event most likely occurred due to differences in the virtual removal of the metallic mesh as compared to how the surgeon dissected the mesh in-situ.Metallic objects can obscure underlying bony details due to image scatter.Small discrepancies in these regions would not be unexpected.The complaint description reports that the surgeon trimmed the small portions of the implant and a bony prominence for a more optimal fit.This is in line with the instructions for use for modification of the implant.The event report states that the surgical outcome after trimming was ¿good¿.The investigation was dispositioned by product development as unconfirmed.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: sd800.427-us.Lot number: 68p3640.Date of manufacture: 08/26/2020.Place of manufacture: brandywine.Part expiration date: n/a (nonsterile).List of nonconformances: none.Description of dhr review: no ncrs were generated during production.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 action.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
• MDR Report Key: 10638220
• MDR Text Key: 211346684
• Report Number: 2939274-2020-04536
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 10887587065007
• UDI-Public: (01)10887587065007
• 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: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• 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: 68P3640
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/05/2020
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: TRAUMA
• Patient Outcome(s): Required Intervention