MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION MAYFIELD MODIFIED SKULL CLAMP; SKULL CLAMPS AND HEADREST SYSTEM

Catalog Number A1059

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

A report was received about an a1059 that was involved in a patient injury.Additional information has been requested.

Manufacturer Narrative

To date, the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based upon the reported information.

• Brand Name: MAYFIELD MODIFIED SKULL CLAMP
• Type of Device: SKULL CLAMPS AND HEADREST SYSTEM
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; cincinnati OH 45227
• Manufacturer Contact: linda serentino ; 315 enterprise dr; 6099365560
• MDR Report Key: 3644966
• MDR Text Key: 4283042
• Report Number: 3004608878-2014-00007
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/08/2014

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2014
• Initial Date FDA Received: 01/31/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1