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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD COMPOSITE SERIES SKULL CLAMP; ¿COMPOSITE SERIES¿
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INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD COMPOSITE SERIES SKULL CLAMP; ¿COMPOSITE SERIES¿ Back to Search Results
Catalog Number A3059
Device Problem Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
It was reported that the twist lock on mayfield skull clamp (a3059) was not working properly.It is unknown if there was patient involvement or if the device failure led to patient injury or surgical delay.
 
Manufacturer Narrative
Device history record - the dhr documentation showed no abnormalities related to the reported failure.Mayfield skull clamp (a3059) was returned for evaluation.The reported complaint was confirmed via inspection of the unit.The mayfield 2 lock had up and down movement and the teeth were grinding when rotated.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.
 
Event Description
N/a.
 
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Brand Name
MAYFIELD COMPOSITE SERIES SKULL CLAMP
Type of Device
¿COMPOSITE SERIES¿
Manufacturer (Section D)
INTEGRA LIFESCIENCES CORPORATION OH/USA
4900 charlemar drive
4900 charlemar drive
cincinnati OH 45227
MDR Report Key11349278
MDR Text Key232577801
Report Number3004608878-2021-00105
Device Sequence Number1
Product Code HBL
Combination Product (y/n)N
PMA/PMN Number
K142238
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 03/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberA3059
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/08/2021
Date Manufacturer Received02/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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