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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD MODIFIED SKULL CLAMP; SKULL CLAMPS AND HEADREST SYSTEMS
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INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD MODIFIED SKULL CLAMP; SKULL CLAMPS AND HEADREST SYSTEMS Back to Search Results
Catalog Number A1059
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
A facility reported that when torque screw is at 60 lbs, the mayfield modified skull clamp (a1059) would not lock into place but when screw is at 40 lbs, it would lock.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 shows no abnormalities related to the reported failure.Mayfield modified skull clamp (a1059) was returned for evaluation.With respect to the returned unit, it has passed all specific functional testing requirements, except for the lock having rotational movement.When the unit is properly positioned and put under pressure the unit will function properly.Evaluation found no device deficiencies that would have contributed to the reported complaint.
 
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Brand Name
MAYFIELD MODIFIED 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 Key11369285
MDR Text Key234076133
Report Number3004608878-2021-00129
Device Sequence Number1
Product Code HBL
Combination Product (y/n)N
PMA/PMN Number
PRE-AMEND
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 04/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberA1059
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/29/2021
Date Manufacturer Received04/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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