MAUDE Adverse Event Report: SYNTHES MEZZOVICO PSI SD800.428 PEEK IMPLANT; PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE

Catalog Number SD800.428

Device Problem Fitting Problem (2183)

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

Event Date 11/24/2014

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the implant curvature does not match with the bone patient curvature; this has led to a significant aesthetic defect.It is not relevant to the health of the patient.There was no prolongation in surgery.The surgeon is not happy with the final aesthetic result of this case, the implant was fixed correctly and contacted perfectly in the defect, covered all the defect, the problem is with the implant projection, the implant doesn¿t have the natural patient curvature and it is projected too much with a unpleasing aesthetic result for the patient.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device has not been reported as explanted.The investigation could not be completed; no conclusion could be drawn, as no product was received.No non-conformance reports 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: ct-scans; pre-op data (psi design, pre-operative).The analysis of the ct data showed that the proposed implant design is very close to the preoperative (pre-resection) ct dataset that we received to investigate this complaint.This preoperative ct dataset was not available for the implant design process.According to our standard process, we used a reference skull to define the implant shape, as the defect was in a centerline position, so there was no healthy anatomy of the patient that could be mirrored.This proposed implant design was approved by the surgeon as he signed the images for approval for this implant.Based on the ct data the trumatch cmf team cannot make any predictions about the soft tissue response to a specific implant design.To take that in consideration is in the responsibility of the surgeon.Device is 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 SD800.428 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: 4352622
• MDR Text Key: 16175219
• Report Number: 1000562954-2014-10226
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 11/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD800.428
• Device Lot Number: 8965045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/13/2015
• Initial Date FDA Received: 12/22/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 72