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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION MAYFIELD INFINITY SKULL CLAMP; SKULL CLAMPS AND HEADREST SYSTEMS
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INTEGRA LIFESCIENCES CORPORATION MAYFIELD INFINITY SKULL CLAMP; SKULL CLAMPS AND HEADREST SYSTEMS Back to Search Results
Catalog Number A1114
Device Problem Device Stops Intermittently (1599)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
The surgeon reported an incident while using the a1114 infinity skull clamp with a child.While in surgery the head loosened from the clamp.He used the blue screw without any other supporting device.He did not read the ifu and was not aware that the blue screw has less force than the silver screw which he normally uses for children.He thought it has the same force, even though 18 pounds is written on the screw.The operating room team was trained on (b)(6) 2014 including everything about using the blue screw with supporting devices.Additional information was requested however, the consultant refused to answer questions.
 
Manufacturer Narrative
The device involved in the reported incident is not expected to be received for evaluation.An investigation has been initiated upon the reported information.
 
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Brand Name
MAYFIELD INFINITY SKULL CLAMP
Type of Device
SKULL CLAMPS AND HEADREST SYSTEMS
Manufacturer (Section D)
INTEGRA LIFESCIENCES CORPORATION
cincinnati OH 45227
Manufacturer Contact
linda serentino
315 enterprise drive
6099365560
MDR Report Key4223713
MDR Text Key4997504
Report Number3004608878-2014-00130
Device Sequence Number1
Product Code HBL
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K051440
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 07/15/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberA1114
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/15/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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