MAUDE Adverse Event Report: AESCULAP INC. (B. BRAUN COMPANY) CLAMP CRANIAL FIXATION/IMPLANT

Lot Number 52151634

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Headache (1880)

Event Date 10/19/2015

Event Type  Injury  

Event Description

Pt.Developed headache, collection noted of epidural fluid and tissue culture, gram stain positive on (b)(6) 2016.Pt.Treated with iv antibiotics and discharged home on (b)(6) 2016 with home iv antibiotic therapy.

• Brand Name: CLAMP CRANIAL FIXATION/IMPLANT
• Type of Device: CLAMP CRANIAL FIXATION/IMPLANT
• Manufacturer (Section D): AESCULAP INC. (B. BRAUN COMPANY); 3773 corporate parkway; center valley PA 18034
• MDR Report Key: 5495457
• MDR Text Key: 40234755
• Report Number: MW5060843
• Device Sequence Number: 2
• Product Code: GXN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/01/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Lot Number: 52151634
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 50