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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION MAYFIELD; HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)
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INTEGRA LIFESCIENCES CORPORATION MAYFIELD; HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP) Back to Search Results
Model Number A1059
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Laceration(s) (1946)
Event Date 04/09/2021
Event Type  malfunction  
Event Description
The neuro resident pinned the patient's head using the mayfield c clamp.The patient was then positioned prone onto the jackson table.The neuro resident was holding the c clamp attached to the patient's head.While flexing the patient's head, there was a clicking sound and the patient's head moved.A laceration was then noted on the patient's left head near one of the mayfield pins.A neuro physician came into the room to assess and did education of pinning to the neuro resident.The attending physician was made aware of incident.Patient was positioned back onto cart, and mayfield c clamp was reapplied.The attending physician assessed, shaved, cleaned up, and stapled laceration.Patient was then positioned back onto the jackson table.C clamp was cleaned and given to service coordinator.
 
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Brand Name
MAYFIELD
Type of Device
HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)
Manufacturer (Section D)
INTEGRA LIFESCIENCES CORPORATION
1100 campus rd
princeton NJ 08540
MDR Report Key11769072
MDR Text Key248878037
Report Number11769072
Device Sequence Number1
Product Code HBL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 04/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberA1059
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/13/2021
Event Location Hospital
Date Report to Manufacturer05/04/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age24455 DA
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