Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD TRIAD SKULL CLAMP; SKULL CLAMPS AND HEADREST SYSTEMS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD TRIAD SKULL CLAMP; SKULL CLAMPS AND HEADREST SYSTEMS Back to Search Results
Catalog Number A1108
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
A facility reported that based on an inspection report, the swivel lock on the mayfield triad skull clamp (a1108) was very loose.
 
Manufacturer Narrative
Mayfield triad skull clamp (a1108) was returned for evaluation.The reported complaint was confirmed.Evaluation showed that the lock has rotational and lateral movement and a residue buildup is present.The unit needs repair, and replacement of worn parts.General maintenance and cleaning required.Device exceeds its expected life of 7 years (manufactured in 2010).No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MAYFIELD TRIAD 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 Key11325771
MDR Text Key234224615
Report Number3004608878-2021-00076
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,user f
Type of Report Initial,Followup
Report Date 03/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberA1108
Device Lot Number101
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/25/2021
Date Manufacturer Received02/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-