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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; N/A

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INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD MODIFIED SKULL CLAMP; N/A Back to Search Results
Model Number A1059
Device Problems Unstable (1667); Mechanics Altered (2984)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The mayfield modified skull clamp (a1059) was returned for evaluation: device history record (dhr) - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - investigation of the returned unit showed that the lock had rotational and lateral movement and a residue buildup was present.The unit was machined to have helicoils added to the large starbursts; new components were added to replace worn internal parts, and general cleaning and maintenance performed.Root cause - complaint confirmed via inspection of the unit.The index knob was loose and required replacement of worn internal parts due to routine use and wear.No further investigation is required based on the acceptability of risk and no adverse trends were identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.
 
Event Description
A facility reported that the locking mechanism of the mayfield modified skull clamp (a1059) was loose and unstable.No information has been provided on patient involvement, injury, or surgical delay.
 
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Brand Name
MAYFIELD MODIFIED SKULL CLAMP
Type of Device
N/A
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 Key17191427
MDR Text Key317814364
Report Number3004608878-2023-00118
Device Sequence Number1
Product Code HBL
UDI-Device Identifier10381780253457
UDI-Public10381780253457
Combination Product (y/n)N
PMA/PMN Number
PRE-AMEND
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 06/23/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberA1059
Device Catalogue NumberA1059
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/31/2023
Date Manufacturer Received06/02/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/19/2017
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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