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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 Unstable (1667)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
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 the mayfield modified skull clamp (a1059) seems to be wobbling.It is unknown if there was patient involvement; however no patient injury or surgical delay has been reported.
 
Manufacturer Narrative
Mayfield modified skull clamp (a1059) was returned for evaluation.Complaint confirmed via inspection of the unit.Unit received with the lock having movement and requiring replacement of worn parts.Unit is beyond integra¿s 7 years recommended life cycle (manufactured in 2005).No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.
 
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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
MDR Report Key11408438
MDR Text Key243908284
Report Number3004608878-2021-00150
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 03/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2021
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 Manufacturer02/22/2021
Date Manufacturer Received03/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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