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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
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INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD MODIFIED SKULL CLAMP Back to Search Results
Catalog Number A1059
Device Problem Device Slipped (1584)
Patient Problem Laceration(s) (1946)
Event Date 11/17/2020
Event Type  Injury  
Manufacturer Narrative
Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
This is 2 of 2 reports which is linked to mfg report number 3004608878-2020-00756.A facility reported that the headrest pins of the mayfield modified skull clamp slipped despite being applied correctly.This resulted in lacerations x2 to the patient's scalp requiring sutures to close.It is unknown if the device failure led to surgical delay.Additional information has been requested.
 
Event Description
N/a.
 
Manufacturer Narrative
Unique device evaluation: (b)(4).Device history record - the dhr shows no abnormalities related to the reported failure.Mayfield skull clamp (a1059) was returned for evaluation.The evaluation of the device cannot duplicate the reported condition.No issues observed from the functional testing and evaluation of the device.Preventative maintenance and cleaning required at this time.
 
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Brand Name
MAYFIELD MODIFIED SKULL CLAMP
Manufacturer (Section D)
INTEGRA LIFESCIENCES CORPORATION OH/USA
4900 charlemar drive
4900 charlemar drive
cincinnati OH 45227
MDR Report Key11076409
MDR Text Key223725346
Report Number3004608878-2020-00757
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 company representative,foreig
Type of Report Initial,Followup
Report Date 12/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberA1059
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2020
Date Manufacturer Received01/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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