MAUDE Adverse Event Report: SYNTHES BRANDYWINE PSI SD800.446; PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

Catalog Number SD800.446

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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

It was reported a surgeon performed a revision surgery on a patient with cranial patient specific implant (psi) which developed an infection.The device was explanted.Additional information received on (b)(6) 2014, indicates the patient was being treated for a cranial defect on the original implant of (b)(6) 2013.On (b)(6) 2013 the implant was removed and replaced during the same procedure to fix bleeding.On (b)(6) 2014 the implant was removed due to infection.Facility contact reported the event was not device related, but may be due to other health factors.This is 1 of 1 report for (b)(4).

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device used for treatment not diagnosis.The part was not returned for evaluation.The lot number is unknown therefore a review of the device history record could not be completed.No conclusion could be drawn, as the part was not received.

Manufacturer Narrative

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 SD800.446
• Type of Device: PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3666920
• MDR Text Key: 4342793
• Report Number: 2520274-2014-10143
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SD800.446
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2014
• Initial Date FDA Received: 03/07/2014
• Supplement Dates Manufacturer Received: 10/13/2017
• Supplement Dates FDA Received: 10/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention