MAUDE Adverse Event Report: SYNTHES MEZZOVICO PSI 160*120*40 PEEK; PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE

Catalog Number SD800.441

Device Problems Inadequacy of Device Shape and/or Size (1583); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/03/2017

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.Explanted date: not explanted.Device is not expected to be returned for manufacturer review/investigation.Device history records review was conducted.The report indicates that the: part #sd800.441 / lot #l462808, manufacturing location: (b)(6), manufacturing date: 13.June 2017.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 condition.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 synthes on an event in (b)(6) as follows: it was reported that during surgery on (b)(6) 2017 the prosthesis excess part was manually milled to permit the correct place in the patient.Material is still implanted.There was no adverse event, and there was no patient harm and the outcome is good.The surgery was not prolonged.The procedure was successfully completed but some manual drilling was required to fit the product specific implant (psi) properly, however, no surgical delay reported and no additional information available at this time.This complaint involves 1 part.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

A manufacturing and product development investigation was performed.Part is not available for investigation as it is still implanted in patient.Involved part is: 1 x sd800.441 / psi 160*120*40 peek / l462808.Pd investigation: the review of the processes and design steps of this specific case showed that the peek psi was designed according our processes.The process and data analysis did not discover any gap or error in the process or in its execution.The print of the perimeter and the peek psi implant representation on a 3d printer showed, that the two 3d models did assemble within each other without any interference or gaps beside the cut the lower temporal region requested by the surgeon.Based on the above discussed situation the complaint is indeterminate as we have any indication about the location or extend of the manual adjustment without the original device, intraoperative pictures or post-operative scans.As indicated in the psi ifu (b)(4) which ships with every peek psi, the peek psi implants are intraoperative adjustable / mill-able.Additionally, due to the work performed by materialise nv, who performed both segmentation and implant design, this complaint will be forwarded to materialise in order to initiate an investigation at their side as well.Supplier investigation: for this complaint involving a segmentation- and design-only case, the segmentation and implant design was reviewed.No issues were found at both stages.The first version of the implant design matches with the segmentation.Both segmentation and implant design were done according to the work instructions.However, the final design was performed by the local depuy-synthes team in italy, after the surgeon had some additional requests.The implant design of the last version was not within control of materialise and could not be reviewed.Overall conclusion: unfortunately we only have limited information in the complaint description and cannot confirm how this happened.Per dhr review the part was manufactured according to the specification.Without material, it is not possible to make a final conclusion, but based on the investigation results we conclude that the cause of failure is not due to any manufacturing non-conformance.No product fault could be detected.(b)(4).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.

• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6788194
• MDR Text Key: 82924440
• Report Number: 1000562954-2017-10173
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 07611819341395
• UDI-Public: (01)07611819341395(10)L462808
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD800.441
• Device Lot Number: L462808
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1