MAUDE Adverse Event Report: SYNTHES MEZZOVICO PSI SD800.435 PEEK IMPLANT; PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE

Catalog Number SD800.435

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

Patient Problems Sedation (2368); No Code Available (3191)

Event Date 09/07/2017

Event Type  Injury  

Manufacturer Narrative

Patient age or date of birth and weight not available for reporting.Device was not explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Hospital address and telephone not available for reporting.The investigation could not be completed; no conclusion could be drawn, as no product was received.(b)(4).Dhr review was completed.Manufacturing location: (b)(4).Manufacturing date: 13.July 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.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 synthes europe reports an event in (b)(6) as follows: it was reported that two (2) product specific implants (psi) were bigger than the requested size.The surgeon completed the surgery by cutting off the excess part.The procedure was prolonged for about 1 hour with aesthetic result compromised.The procedure was successfully completed.This report is for one (1) psi peek implant.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

The complained device was not returned.Product development conducted an investigation based on the information provided.Our investigation has shown that no material was received.The manufacturing review does show that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.We have forwarded this complaint to the product development department and supplier for further investigation with the following results: investigation product development department: 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.We did also print the perimeter and the peek psi implant representation on our 3d printer and the two 3d models did assemble within each other without any interference or gaps.The complaint is indeterminate as we don¿t have enough indication about the location or extend of the manual adjustment despite the intraoperative pictures, but without the original device, or post-operative scans a deeper analysis of the root cause is not possible.As indicated in the psi ifu 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 the segmentation, this complaint will be forwarded to materialise in order to initiate an investigation at their side as well.Investigation supplier: for this segmentation-only case, the lmageq and segmentation were investigated.No inaccuracies were found at both stages.The segmentation was performed according to the work instructions.As materialise was only responsible for the segmentation and the segmentation was done correctly, no root cause was determined for this complaint.Overall conclusion: based on the investigation results we conclude that the cause of failure is not due to any manufacturing non-conformances.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 SD800.435 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6901708
• MDR Text Key: 87661936
• Report Number: 1000562954-2017-10223
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 07611819341357
• UDI-Public: (01)07611819341357(10)L501954
• 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: 09/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD800.435
• Device Lot Number: L501954
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention