MAUDE Adverse Event Report: SYNTHES BRANDYWINE PSI SD800.420 PEEK IMPLANT; PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE

Catalog Number SD800.420

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

Patient Problems Unspecified Infection (1930); Fluid Discharge (2686)

Event Type  Injury  

Event Description

It was reported that a patient was treated with cranioplasty using synthes psi implant approx 2 weeks ago.Patient had cranial defect from removal of brain tumor.The tumor was removed approx one year ago.The patient has a history of infection issues.The wound was treated with irrigation and drainage following removal of the implant.Cultures were sent to lab to confirm suspected infection.Hardware was successfully removed.This report is 7 of 8 for (b)(4).

Manufacturer Narrative

(b)(4).Device history records was conducted.The report indicates that the: reviewed scanned documentation in the dhr for psi device (b)(4)).Documentation shows this device was manufactured, etched, inspected, cleaned and forward for plasma treatment as per model specifications supplied by cmf product development on (b)(4) 2014.Date of release to warehouse was (b)(4) 2014.Raw material (lot 7571060) was reviewed.No issues identified.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PSI SD800.420 PEEK IMPLANT
• Type of Device: PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE
• 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4766410
• MDR Text Key: 19648388
• Report Number: 2530088-2015-10237
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SD800.420
• Device Lot Number: 7729769
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 83