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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD INFINITY SKULL CLAMP; SKULL CLAMPS AND HEADREST SYSTEMS
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INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD INFINITY SKULL CLAMP; SKULL CLAMPS AND HEADREST SYSTEMS Back to Search Results
Catalog Number A1114
Device Problem Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The device was not yet returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.
 
Event Description
A customer reported that the a1114 mayfield infinity skull clamp did not clamp all the way down on one side on an unknown date.Additional information received on 17sep2019 indicating that the product problem occurred during application of the mayfield in a craniotomy procedure.There was no harm to the patient.A surgery delay of less than 10-minute was noted.
 
Manufacturer Narrative
The device was returned for evaluation.The right side boss threaded hole was cross threaded.The unit needed to be machined to have heli-coils added to large starburst threads.The reported complaint was confirmed from the evaluation of item.The definite root cause of the reported complaint could not be reliably determined.
 
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Brand Name
MAYFIELD INFINITY SKULL CLAMP
Type of Device
SKULL CLAMPS AND HEADREST SYSTEMS
Manufacturer (Section D)
INTEGRA LIFESCIENCES CORPORATION OH/USA
4900 charlemar drive
4900 charlemar drive
cincinnati OH 45227
MDR Report Key9167381
MDR Text Key189722079
Report Number3004608878-2019-01039
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 user facility
Type of Report Initial,Followup
Report Date 09/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2019
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? Device Returned to Manufacturer
Date Returned to Manufacturer09/18/2019
Date Manufacturer Received10/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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