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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD COMPOSITE SERIES SKULL CLAMP; ¿COMPOSITE SERIES¿
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INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD COMPOSITE SERIES SKULL CLAMP; ¿COMPOSITE SERIES¿ Back to Search Results
Catalog Number A3059
Device Problem Device Slipped (1584)
Patient Problem Laceration(s) (1946)
Event Date 10/24/2023
Event Type  Injury  
Event Description
A facility reported that during an ortho spine case, the mayfield composite series skull clamp (a3059) slipped causing a skull laceration.No delay greater than 30 minutes was reported.Patient injury is attributed to possible malfunction, or possible misuse by user.
 
Manufacturer Narrative
The mayfield composite series skull clamp (a3059) was returned for evaluation: device history record (dhr): the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - the investigation of the returned device found no device deficiencies that would have contributed to the reported complaint.The device passed all specific functional testing requirements except for having slight movement in the lock.Despite the movement, when the clamp is properly positioned and put under pressure, it will not move.Unit was sent to quality engineering (qe) for further investigation.Qe confirmed the initial findings, and no additional device deficiencies were noted.To resolve the slight movement in the lock, the disk ratchet and retainer were replaced; new components were added to replace worn internal parts, along with general maintenance and cleaning performed.Root cause - evaluation found no device deficiencies that would have contributed to the reported complaint.Probable root cause is improper or suboptimal placement of the skull clamp on the patient.No further investigation is required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.
 
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Brand Name
MAYFIELD COMPOSITE SERIES SKULL CLAMP
Type of Device
¿COMPOSITE SERIES¿
Manufacturer (Section D)
INTEGRA LIFESCIENCES CORPORATION OH/USA
4900 charlemar drive
4900 charlemar drive
cincinnati OH
Manufacturer (Section G)
INTEGRA LIFESCIENCES CORPORATION OH/USA
4900 charlemar drive
cincinnati OH
Manufacturer Contact
vivian nelson
1100 campus drive
princeton, NJ 
6099362319
MDR Report Key18196660
MDR Text Key328887042
Report Number3004608878-2023-00215
Device Sequence Number1
Product Code HBL
UDI-Device Identifier10381780253792
UDI-Public10381780253792
Combination Product (y/n)N
PMA/PMN Number
K142238
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 11/22/2023
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? No
Device Operator Health Professional
Device Catalogue NumberA3059
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/09/2023
Initial Date Manufacturer Received 11/02/2023
Initial Date FDA Received11/22/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/18/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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