MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD 2000 RADIOLUCENT SKULL CLAMP; SKULL CLAMPS AND HEADREST SYSTEMS

Catalog Number A2002

Device Problems Sticking (1597); Positioning Problem (3009)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Event Description

The first week in (b)(6), a patient in his (b)(6) was prepped and positioned in the a2002 skull clamp.When surgeon wanted to rotate the 80 lbs torque screw of a mayfield 2000 radiolucent skull clamp, the engagement mark was not visible.The index shaft was not coming out even after the fixation of skull pin on the skull.Index knob got stuck.This event occurred 6 hours into the surgery.The event caused a "small bleeding of the skin." there was a delay of 25-30 minutes while another mayfield skull clamp was obtained.The patients' head was held while the second unit was being setup.

Manufacturer Narrative

The device involved in the reported incident has been received for evaluation.An investigation has been initiated based upon the reported information.

• Brand Name: MAYFIELD 2000 RADIOLUCENT SKULL CLAMP
• Type of Device: SKULL CLAMPS AND HEADREST SYSTEMS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; cincinnati OH 45227
• Manufacturer Contact: linda serentino ; 315 enterprise dr; 6099365560
• MDR Report Key: 3724501
• MDR Text Key: 17924483
• Report Number: 3004608878-2014-00024
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K953124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A2002
• Device Lot Number: 091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR