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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD 2000 RADIOLUCENT SKULL CLAMP

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INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD 2000 RADIOLUCENT SKULL CLAMP Back to Search Results
Catalog Number A2002
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
This mdr is being submitted as part of service and repair remediation activities associated with capa (b)(4).The device was returned to the manufacturer for service and repair.The unit was cleaned per protocol.It was noted upon inspection that the returned unit did not meet all specific functional tests.The unit was received with the plunger cap broken off of the plunger stud from mishandling of the unit; repair cannot duplicate the locking problem: general maintenance and cleaning required.A review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances related to the reported failure.
 
Event Description
The user facility returned the a2002 mayfield 2000 radiolucent skull clamp for service and repair because the lock was broken.
 
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Brand Name
MAYFIELD 2000 RADIOLUCENT SKULL CLAMP
Manufacturer (Section D)
INTEGRA LIFESCIENCES CORPORATION OH/USA
4900 charlemar drive
4900 charlemar drive
cincinnati OH 45227
Manufacturer (Section G)
INTEGRA LIFESCIENCES CORPORATION OH/USA
4900 charlemar drive
cincinnati OH 45227
Manufacturer Contact
kimberly shelly
311 enterprise drive
plainsboro, NJ 08536
6099362319
MDR Report Key8948172
MDR Text Key190035952
Report Number3004608878-2019-00498
Device Sequence Number1
Product Code HBL
Combination Product (y/n)N
PMA/PMN Number
K953124
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial
Report Date 08/14/2019
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 Catalogue NumberA2002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/10/2017
Initial Date Manufacturer Received 08/14/2019
Initial Date FDA Received08/29/2019
Was Device Evaluated by Manufacturer? Yes
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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