MAUDE Adverse Event Report: SYNTHES MEZZOVICO PSI SD800.401 PEEK IMPLANT; PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE

Catalog Number SD800.401

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Sedation (2368)

Event Date 09/17/2015

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Implant date sometime in (b)(6) 2015.Not explanted.(b)(6).Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records was conducted.The report indicates that the: manufacturing site: (b)(4).Manufacturing date: 20 july 2015 part sd800.401 lot 9577746, no ncrs were generated during production.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Report from synthes europe reports an event in (b)(6) as follows: it was reported implant did not fit patient, surgery was performed in (b)(6).The surgery time extended 60 minutes.Patient requires further scan to design new psi.This complaint involves one part (b)(4).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

A product development evaluation was completed: the complaint is unconfirmed as the device was made according to the form the surgeon signed approval documentation.The reconstruction was designed according the visual defect represented in the patients ct dataset.However, the provided ct dataset had a slice thickness of 2.5mm instead of the requested 1.0mm for the original data.Besides that, there was derived data with a 0.625mm slice thickness available, but as this dataset is recalculated from the original dataset, it should not be used, as it would contain the same uncertainties, as the original data with the 2.5mm slice thickness.If the trumatch cmf team detects such a case, where the ct data quality is not according our specification, then the surgeon will be asked to provide the trumatch cmf team with a new ct dataset or give an according e-mail approval that the use of the provided ct dataset is ok with the surgeon.At the time point the ct dataset for case 215464 was segmented, the trumatch cmf team did work on a project in collaboration with materialise to let materialise segment the ct data, using their interface software proplan cmf online to exchange case data including ct data.Therefore the before mentioned communication e-mail was not send out.However, the use of 2.5mm ct dataset to design the plate was also highlighted on the images for approval documentation that need to be signed by the surgeon to approve the proposed psi design proposal.The following effects that do occur in this case may influence the quality of an orbital floor reconstruction, using a peek psi: thin bone thickness in the orbital floor region, combined with the slice thickness of 2.5mm may lead to undetected bone structure, a present, metallic orbital floor implant, that was segmented out form the ct dataset may negatively influence the interpretation of the bony structure due to the metallic artifacts, due to the limited access to the bony structure in this anatomical region, it may be difficult to clean the bone from the soft tissue, to assure a proper fit of the psi implant, as the slice thickness and metallic orbital floor implant removal is highlighted in the order and images for approval, that need to be signed by the surgeon, we focus in this complaint evaluation on the cleaning of the bone interface.No product related fault could be detected; the device was made according to the form the surgeon signed approval.Device was not implanted/explanted.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 SD800.401 PEEK IMPLANT
• Type of Device: PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer (Section G): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5271778
• MDR Text Key: 32865485
• Report Number: 1000562954-2015-10213
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK053199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD800.401
• Device Lot Number: 9577746
• Other Device ID Number: (01)10887587064789(10)9577746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention