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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD 2000 SKULL CLAMP; SKULL CLAMPS AND HEADREST SYSTEMS
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INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD 2000 SKULL CLAMP; SKULL CLAMPS AND HEADREST SYSTEMS Back to Search Results
Catalog Number A2000
Device Problems Unstable (1667); Out-Of-Box Failure (2311)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
It was reported that an a2000 mayfield 2000 skull clamp double ended swivel did not stabilize a pt's head at 60 pounds of pressure.This was considered an out of box failure and the unit was in contact with the pt.There was no revision or injury and it is unk whether there was a delay in surgery as a result of this issue.Add'l info received was as follows: "the skull clamp was put on our pt, using 60 pounds of pressure, and the head was still moving a little so we exchanged the clamp for another.There was no injury to the pt, just frustration by the surgeon.I use re-useable skull pins.".
 
Manufacturer Narrative
To date, the device involved in the reported incident has not been received for eval.An investigation has been initiated based upon the reported info.
 
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Brand Name
MAYFIELD 2000 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 Key4752272
MDR Text Key5827560
Report Number3004608878-2015-00134
Device Sequence Number1
Product Code HBL
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K932807
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 04/09/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberA2000
Device Lot Number067
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/09/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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