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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
Catalog Number A1059
Device Problem Device Slipped (1584)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
A facility reported the locking mechanism of the mayfield skull clamp was not engaging, or slipping.The issue was noted during an internal service.There was no patient involvement, or surgery delay.
 
Manufacturer Narrative
Udi: (b)(4).Device history record (dhr) - the dhr shows no abnormalities related to the reported failure.The reported complaint was confirmed from the visual evaluation of the returned mayfield skull clamp.The lock had movement and a residue buildup is present , the index knob and the lock had worn parts.Replacements, repair and pm is required at this time.The observed condition is likely caused by wear and tear / improperly handling of the device.The definite root cause cannot be reliably determined.
 
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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 45227
MDR Report Key10891985
MDR Text Key217964125
Report Number3004608878-2020-00690
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 10/28/2020
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 Catalogue NumberA1059
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/03/2020
Initial Date Manufacturer Received 10/28/2020
Initial Date FDA Received11/24/2020
Supplement Dates Manufacturer Received12/07/2020
Supplement Dates FDA Received12/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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