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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 Laceration(s) (1946)
Event Date 12/01/2022
Event Type  Injury  
Event Description
This is 2 of 2 reports linked to mfg report number 3004608878-2022-00284: a facility reported that 1 of 2 mayfield modified skull clamps (a1059) caused harm to a patient resulting in a 3 inch laceration of the scalp.The mayfield was not holding the pounds of pressure after being put to 60lbs, and the patient's head did slip while fixated.The mayfield devices were changed out after that and cleaned, but the facility is not sure which one was not holding.As a result, both devices have been returned for evaluation.Additional information received indicates the following: the patient was initially positioned prone for posterior cervical procedure.No repositioning.The patient's head was fixed for about 10-15 mins before it was noticed it wasn't holding the pounds of pressure.Type of surgery was posterior cervical.There was no delay.Staples were applied to laceration before the surgical procedure started.Mayfield headrest was switched out for a new one.Surgery proceeded.Patient outcome/current condition is stable.
 
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: evaluation of the returned unit found no device deficiencies that would have contributed to the reported complaint.Service and repair (s&r) could not duplicate slippage and found that when the clamp was properly positioned and put under pressure the unit will function properly.Unrelated to the reported complaint, the lock had both rotational and lateral movement and a residue buildup was present.Upon disassembly, it was noted that the index knob and the lock had new components added to replace worn internal parts.New components were added to replace worn internal parts and general maintenance and cleaning performed.Further investigation by quality engineering confirms the findings of the s&r report.Unit showed signs of wear and there was slight movement observed in the lock.Root cause: 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.
 
Manufacturer Narrative
Updated fields: g3, g6, h2, h10, h11 corrected field: d9, h6 (type of investigation).This mdr is being submitted for correction of errors in fields d9 and h6 of the initial mdr.
 
Event Description
N/a.
 
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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 Key16040394
MDR Text Key306062854
Report Number3004608878-2022-00285
Device Sequence Number1
Product Code HBL
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
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/27/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberA1059
Device Catalogue NumberA1059
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/14/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received01/26/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/10/2020
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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