MAUDE Adverse Event Report: SYNTHES MEZZOVICO PSI SD800.440 PEEK IMPLANT; PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE

Catalog Number SD800.440

Device Problem Fitting Problem (2183)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 04/27/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient information not available for reporting.Not explanted.Device is not expected to be returned for manufacturer review/investigation.The surgeon felt that the implant was designed poorly and the fit is compromised.Material is still implanted.Device history records was conducted.The report indicates that the manufacturing location: (b)(4), manufacturing date: 13 april 2016, catalog #sd800.440 / lot #9917927.No ncr's were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the 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 the operation, the fitting of the patient specific implant (psi) is poor and unable to get the right fit.The surgeon felt that the implant has been designed poorly and the fit is compromised.Material is still implanted.There was no patient harm, the surgery was not prolonged and the patient condition is stable.The surgery was successfully completed.This complaint involves 1 part.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

(b)(6).A product development evaluation was completed: the device was not returned for evaluation; the provided pictures were evaluated.About 2-3 years ago it was requested in (b)(6) that the psi implants for (b)(6) be provided with a specific offset of 1.0mm to have an easier peek psi implant placement within the patients defect, even if not all of the surrounding soft tissue is stripped off the bony defect.The standard offset for all the other peek psi cases is 0.2mm.From that time point on all the peek psi cases for (b)(6) where provided with that specific offset.If a surgeon is then stripping off all the soft tissue in the bony defect, then the 1.0mm setup may lead to inappropriate fit as described above.This effect is also visible on some provided pictures, that where taken intraoperative.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 SD800.440 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: 5654233
• MDR Text Key: 45159159
• Report Number: 1000562954-2016-10108
• 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
• Report Date: 04/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD800.440
• Device Lot Number: 9917927
• Other Device ID Number: 01) 07611819341388(10)9917927
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1