MAUDE Adverse Event Report: SYNTHES BRANDYWINE PSI SD800.441; PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

Catalog Number SD800.441

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 patient, implanted with a patient specific implant (psi), was admitted for incisional drainage and swelling.A ct scan, taken on an unknown date, revealed fluid collection consistent with an abscess.Bacterial cultures, collected on an unknown date, revealed staph aureus.Patient was placed on antibiotics.The surgeon plans to return the patient to the operating room to debride the area and to remove the patient specific implant (psi).Per additional information received, the implant was removed on (b)(6) 2014.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 was used for treatment not diagnosis.(b)(6).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 SD800.441
• 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: 3671123
• MDR Text Key: 4344552
• Report Number: 2520274-2014-10014
• 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: 02/08/2014

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: SD800.441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2014
• Initial Date FDA Received: 03/10/2014
• 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
• Patient Age: 56 YR
• Patient Weight: 64