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 COMPOSITE SERIES SKULL CLAMP; ¿COMPOSITE SERIES¿
  • 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 COMPOSITE SERIES SKULL CLAMP; ¿COMPOSITE SERIES¿ Back to Search Results
Catalog Number A3059
Device Problem Unstable (1667)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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 side of the mayfield skull clamp that holds the single pin was unstable when engaged in the patient's skull.It is unknown if there was patient involvement or if the device failure led to patient injury or surgical delay.
 
Event Description
N/a.
 
Manufacturer Narrative
(b)(4).Device history record (dhr): the dhr shows no abnormalities related to the reported failure.Failure analysis & root cause analysis: mayfield skull clamp was received with the mayfield 2 lock having up and down movement and the teeth were grinding when rotated.Complaint not confirmed via inspection of the unit.Evaluation found when the clamp is positioned properly under pressure, it would not slip.Unit required general maintenance and cleaning.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 COMPOSITE SERIES SKULL CLAMP
Type of Device
¿COMPOSITE SERIES¿
Manufacturer (Section D)
INTEGRA LIFESCIENCES CORPORATION OH/USA
4900 charlemar drive
4900 charlemar drive
cincinnati OH 45227
MDR Report Key10891805
MDR Text Key218010561
Report Number3004608878-2020-00698
Device Sequence Number1
Product Code HBL
Combination Product (y/n)N
PMA/PMN Number
K142238
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 10/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberA3059
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2020
Date Manufacturer Received11/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-