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

Catalog Number SD800.402

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Sedation (2368)

Event Date 03/13/2014

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the patient specific implant was a perfect fit to the undersurface bone.However, the surgeon felt it was too prominent and therefore not symmetrical with the other side of the face.This required the surgeon to shave off a considerable amount of the thickness of the implant which added approximately forty-five to sixty minutes onto the case.There was no patient harm, just additional surgical time to try and achieve best cosmetic result.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Explant date: device was not explanted.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.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

Additional narrative: a product development evaluation was completed: no device was received for evaluation.The product was produced as approved and ordered.The implant was designed with the mirroring technique: the healthy side of the patient¿s anatomy was mirrored into the unhealthy area, the connection to the underlying bone then need to be adjusted in order to make the patient specific implant fit to the underlying bony structure in that area.Following this technique the symmetry of the reconstructed shape will not be perfect, but need to be judged by the surgeon if the achieved symmetry is answering the clinical requirement.Therefore the surgeon received images for approval and a 3d printed model.He requested a change not related to the geometry in question in this complaint.In the second loop he received revised images for approval and a file of the skull with a 3d viewer to evaluate the proposed solution.After this second loop, the surgeon did approve the proposal based on the documentation and tools he received.An online planning session was not requested by the surgeon.The product was produced according to ordered specification.Due to the specific anatomical and clinical situation of this patient, the implant did not result in a fully symmetrical anatomy.However the images, models and files sent to the surgeon allow for a detailed assessment of the implant prior to release the design and order the patient specific implant.Without material no clear disposition is possible; however, the device was made according to ordered specification.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 SD800.402 PEEK IMPLANT
• Type of Device: PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH68 05; SZ CH6805
• Manufacturer (Section G): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH68 05; SZ CH6805
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3767928
• MDR Text Key: 4359072
• Report Number: 1000562954-2014-10058
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK033868
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SD800.402
• Device Lot Number: 8773725
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention