MAUDE Adverse Event Report: AESCULAP KERRISON; RONGEUR 1MM/180MM

Model Number FF771R

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 02/09/2014

Event Type  Injury  

Event Description

During artificial cervical disk replacement surgery the surgeon was using the kerrison rongeur and the tip broke off inside the patient's neck.It was identified inside the patient's neck and removed prior to the completion of surgery.

• Brand Name: KERRISON
• Type of Device: RONGEUR 1MM/180MM
• Manufacturer (Section D): AESCULAP; center valley 18034
• MDR Report Key: 4541105
• MDR Text Key: 20014534
• Report Number: MW5040861
• Device Sequence Number: 1
• Product Code: HTX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF771R
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/13/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 81