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

Catalog Number SD800.428

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

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

Event Date 02/19/2016

Event Type  malfunction  

Manufacturer Narrative

Patient information is unknown; device has not been reported as explanted.Complainant part is not expected to be returned for manufacturer review/investigation; device reportedly still implanted.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.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 the patient specific implant (psi) did not fit right during surgery; the psi did not fit 100% with patient skull defect.The psi was still usable and was still implanted; the surgery was not delayed and was successfully completed.Patient outcome was reported as stable.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Manufacturing location: (b)(4).Manufacturing date: january 29, 2016.No non-conformance reports 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.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

(b)(6).Product development evaluation: approximately 2-3 years ago, the sales team in (b)(4) requested that the psi team send a specific offset of 1.0mm in order to have an easier peek psi implant placement within the patients¿ defects.The request was made for when not all of the surrounding soft tissue is stripped off of the bony defect.From that time point on, all the peek psi cases for singapore were provided with that specific offset.The standard offset for all the other peek psi cases is 0.2mm.If a surgeon is strips off all the soft tissue in a patient¿s bony defect, then the 1.0mm setup may lead to inappropriate fit as described in the complaint condition.As no post-operative scans were available for this particular case, this assumption cannot be confirmed.However, it is likely that the increased offset led to the observed effect.Based on the above situation, the manufacturer will provide the 1.0mm setup only based on specific requests moving forward for each singapore case.At this time, this complaint will be closed as ¿indeterminate.¿ 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.Pd docs for this psi device reviewed.

• Brand Name: PSI SD800.428 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5549980
• MDR Text Key: 42616390
• Report Number: 8030965-2016-12247
• 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
• Report Date: 03/15/2016

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: 9820656
• Other Device ID Number: (01)07611819341319(10)9820656
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2016
• Initial Date FDA Received: 04/06/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/21/2016; 05/13/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/29/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 46 YR