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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 Physical Resistance/Sticking (4012)
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 customer reported that locking mechanism on mayfield infinity skull clamp (a1114) sticks.It is unknown if there was patient involvement; however, no patient injury or surgical delay has been reported.
 
Manufacturer Narrative
Device history record: the dhr shows no abnormalities related to the reported failure.Mayfield infinity skull clamp (a1114) was returned for evaluation.The reported complaint was confirmed via inspection of the unit.Unit received with the lock needing replacement of worn internal parts.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 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
MDR Report Key11599674
MDR Text Key243335163
Report Number3004608878-2021-00229
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
Type of Report Initial,Followup
Report Date 04/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2021
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 Manufacturer03/25/2021
Date Manufacturer Received04/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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