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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 Loose or Intermittent Connection (1371)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The device was not yet received by the manufacturer for evaluation.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.
 
Event Description
A biomedical engineer reported that the a1059 mayfield modified skull clamp rocker arm was still loose when locked.The device was not in contact with patient and no patient injury reported.Additional information has been requested.
 
Event Description
N/a.
 
Manufacturer Narrative
Unique device identifier #: (b)(4).The device was returned for evaluation.No dhr review was possible as no other serial number was provided during the course of the complaint investigation.The complaint was confirmed.The returned unit was received with rotational and lateral movement of the locking mechanism along with residue buildup.Locking mechanism was loose and multiple components needed to be replaced due to wear and tear.
 
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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 Key10282270
MDR Text Key203693586
Report Number3004608878-2019-01144
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 health professional,user faci
Type of Report Initial,Followup
Report Date 12/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2020
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 Manufacturer01/24/2020
Date Manufacturer Received03/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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