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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA STANDARD INFINITY SKULL CLAMP; N/A
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INTEGRA LIFESCIENCES CORPORATION OH/USA STANDARD INFINITY SKULL CLAMP; N/A Back to Search Results
Catalog Number A1114A
Device Problem Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The device involved in the reported incident has been received for evaluation.An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
A facility reported that locking device on the mayfield skull clamp was not holding.There was no known injury or surgery delay.
 
Manufacturer Narrative
Unique device identifier (udi): (b)(4).The infinity skull clamp was returned for evaluation and it has passed all specific functional testing requirements, except for the lock having rotational movement.When unit is properly positioned and put under pressure, the unit will function properly.Unit received with the pedi rocker arm instead of the standard rocker arm.Complaint not confirmed via inspection of the unit.
 
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Brand Name
STANDARD INFINITY SKULL CLAMP
Type of Device
N/A
Manufacturer (Section D)
INTEGRA LIFESCIENCES CORPORATION OH/USA
4900 charlemar drive
4900 charlemar drive
cincinnati OH 45227
MDR Report Key10820212
MDR Text Key216945368
Report Number3004608878-2020-00652
Device Sequence Number1
Product Code HBL
Combination Product (y/n)N
PMA/PMN Number
K051440
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 10/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberA1114A
Device Lot Number129
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2020
Date Manufacturer Received11/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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