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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; SKULL CLAMPS AND HEADREST SYSTEMS

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INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD MODIFIED SKULL CLAMP; SKULL CLAMPS AND HEADREST SYSTEMS Back to Search Results
Model Number A1059
Device Problem Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
A facility reported that the locking knob on a mayfield modified skull clamp (a1059) came out of the fixation mechanism.It is unknown if there was patient involvement; however, no patient injury or surgical delay has been reported.
 
Manufacturer Narrative
The mayfield skull clamp (a1059) was returned for evaluation: device history record (dhr) - the dhr was reviewed and no anomalies related to the reported failure was observed.Failure analysis - the device was returned and evaluated confirming the complaint.It was discovered that the unit has rotational and lateral movement, however residue buildup is present and internal parts worn.General maintenance and cleaning is required.Root cause - based on evaluation by integra service and repair, the root cause is most likely the need for routine preventive maintenance due to normal wear.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.
 
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Brand Name
MAYFIELD MODIFIED 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
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 Key13019318
MDR Text Key290287228
Report Number3004608878-2021-00691
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 12/16/2021
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 Health Professional
Device Model NumberA1059
Device Catalogue NumberA1059
Device Lot Number200311(2020)
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2021
Initial Date Manufacturer Received 11/24/2021
Initial Date FDA Received12/16/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/11/2020
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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