MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PSI SD800.402 PEEK IMPLANT; PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE

Catalog Number SD800.402

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/09/2020

Event Type  malfunction  

Manufacturer Narrative

510k: this report is for an unknown psi implant/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.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 during a procedure to treat a benign osteoma, the peek implant did not mirror a healthy frontal sinus.The implant replicated the defective anatomy resulting in compromised cosmetic result.The procedure was successfully completed.This report is for one (1) unknown psi implants.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.A1: patient identifier reported as:(b)(6).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

Product development confirmed that there were two (2) psi peek implants associated with this id case.This report is for one (1) psi sd800.402.Peek implant.This is report 1 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, h4, h6: part sd800.402, lot 64p0606: manufacturing site: mezzovico.Release to warehouse date: july 22, 2020.A manufacturing record evaluation was performed for the not sterile device lot number, and no non-conformances were identified.H3, h6: a design review was completed: an investigation was conducted into the device design to determine if the design contributed or caused the event of the described compromised cosmetic result.With the complaint we did not received any post-operative images or scans to assist with the device investigation and/or to visualize the cosmetic results.A planning session with the operating surgeon was performed regarding the tumor resection and an initial implant design (two-piece design) was discussed.Another planning session was held and the initial resection plan was revisited and modified to have grater radian in the resection corners which allow for an easier intra-operative resection and implant design.The new resection and implant design were reviewed in detail during the planning session with the surgeon.The approval letter document was signed with no requests for changes by the surgeon.The general design for the implant was created; the implant was designed with a standard thickness of 3 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 for psi designs.Per the investigation description above the psi case file was reviewed.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 tumor resection plan and implant design was approved by the surgeon with his signature on the approval letter.Therefore, this non-manufacturing complaint investigation did not identify a design defect or deficiency which potentially contributed to the reported complaint conditions and is closed by product development as undetermined regarding the root cause.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 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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 further reported that both implants were used, as the design of the peek interlocked two segments to aid with implant insertion.

• Brand Name: PSI SD800.402 PEEK IMPLANT
• Type of Device: PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10691218
• MDR Text Key: 211718249
• Report Number: 8030965-2020-08008
• Device Sequence Number: 1
• Product Code: GXN
• 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,Followup
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD800.402
• Device Lot Number: 64P0606
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/15/2020
• Patient Sequence Number: 1
• Treatment: PSI 30*30*40 PEEK