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

Lot Number 52013660

Device Problem Insufficient Information (3190)

Patient Problem Bacterial Infection (1735)

Event Date 07/07/2014

Event Type  Injury  

Event Description

On (b)(6) 2015 report of positive propionibacterium acnes of tissue/head cultures.Pt treated with iv antibiotics (ivab) and d/ch home on (b)(6) 2015 with continued ivab 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: 5495403
• MDR Text Key: 40254516
• Report Number: MW5060838
• 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: 07/08/2019
• Device Lot Number: 52013660
• 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: 64 YR
• Patient Weight: 73