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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD 2000 SKULL CLAMP; SKULL CLAMPS AND HEADREST SYSTEMS
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INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD 2000 SKULL CLAMP; SKULL CLAMPS AND HEADREST SYSTEMS Back to Search Results
Catalog Number A2000
Device Problem Material Deformation (2976)
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 pin hole in the ratchet extension of the a2000 mayfield skull clamp was deformed.The date of the event was not specified.It was unknown if there was patient contact, injury, or surgery delay.Additional information has been requested.
 
Event Description
N/a.
 
Manufacturer Narrative
The device was returned for evaluation.With respect to the returned device it has passed all specific functional testing requirements.Device was recently repaired and will be repaired as a minor repair.Device history record reveals no abnormalities related to the reported failure.The devices manufactured during this period passed all required inspection points with no associated mrr¿s, variances or rework.The failure mode reported was unconfirmed.
 
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Brand Name
MAYFIELD 2000 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 Key7745283
MDR Text Key115909026
Report Number3004608878-2018-00147
Device Sequence Number1
Product Code HBL
Combination Product (y/n)N
PMA/PMN Number
K932807
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 07/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberA2000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/31/2018
Date Manufacturer Received10/04/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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