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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  
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: the investigation showed that the unit was received with the lock having rotational and lateral movement and a residue buildup was present.New components were added to replace the worn internal parts, and general maintenance and cleaning was performed.Root cause analysis: complaint confirmed via inspection of the unit.The unit had a loose lock due to residue and worn parts inside the lock.Potential root cause is normal wear and tear.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 surgeon reported that the pins on the mayfield modified skull clamp (a1059) was not holding pressure.The facility has not reported if there was patient involvement, injury, or surgical delay relative to this event.
 
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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 Key15563157
MDR Text Key302082742
Report Number3004608878-2022-00209
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 10/07/2022
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 Number187
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/15/2022
Initial Date Manufacturer Received 09/16/2022
Initial Date FDA Received10/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/07/2018
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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