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 Problems Fistula (1862); Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.Dhr review - manufacturing location: (b)(4).Manufacturing date: 10.Sep 2015.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 (b)(4) reports an event in (b)(6) as follows: it was reported that on (b)(6) 2015, a patient with facial trauma experienced a right orbit malar depression and as a result underwent surgery to correct the facial trauma utilizing a patient specific implant (psi) which was applied through the patient's mouth.Ten (10) days post-operatively the patient had an infection, fistula and implant exposition.The patient had the device explanted on (b)(6) 2015.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Product development evaluation: in a ct dataset, no visibility to the soft tissue situation (i.E.Presence of scar tissue) was provided.In such a case, the surgeon needs to determine to what extend an augmentation of the existing bone can be supported by the covering soft tissue.For such onlay implants, if the flexibility of the soft tissue is not considered or is limited while covering the implant, then the opportunity for an infection or dehiscence may be presented.The provided peek psi design was according to the design that was released by the surgeon.Based on the provided information, it is not possible to determine the reason for infection.The part was not returned for investigation; therefore, an actual evaluation could not be performed.No indication was found linking the psi to a causal relationship with the infection.Device 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

Device was used for treatment, not diagnosis.Additional narrative: the subject device has been received and is currently in the evaluation process.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product development investigation was performed for the subject device (psi sd800.402 peek implant, part number sd800.402, lot number 9644472).The received subject device was visually inspected and described as a reprocessed peek psi with cutting marks.The cutting marks may have been made during the removal of the implant.According to the given information on the device report a patient presents infection at the area of the implanted psi.The review of the production history revealed that this article was manufactured in september 2015 according to the specifications.No manufacturing related issues that would have contributed to this complaint were found.In a ct dataset no visibility to the soft tissue situation, mainly if scare tissue is present, is given.In such a case the surgeon need to determine, to what extend an augmentation of the existing bone can be supported by the covering soft tissue.For such onlay implants, if the flexibility of the soft tissue is not considered or is limited while covering the implant, then the opportunity for an infection or dehiscence may be presented.The provided peek psi design was according the design that was released by the surgeon.Based on the provided information and on the explanted and returned peek psi, we are not able to determine the reason of the infection further.The complaint condition could not be confirmed.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 CH680 5; SZ CH6805
• Manufacturer (Section G): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5503595
• MDR Text Key: 40405748
• Report Number: 1000562954-2016-10061
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2016
• 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: 9644472
• Other Device ID Number: (01)07611819337749(10)9644472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR