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 Material Too Rigid or Stiff (1544)
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.Linked to mfg report number 3004608878-2020-00647.
 
Event Description
This is 2 of 2 reports.A facility reported that the locking knob on the mayfield skull clamp was not locking properly and was stiff to close.There was no known injury or surgery delay.
 
Manufacturer Narrative
Unique device identifier: (b)(4).Device history record (dhr) - the dhr shows no abnormalities related to the reported failure.Complaint confirmed via inspection of the unit.For the returned mayfield skull clamp, the index knob was stiff to turn and the ratchet extension sticking.These issues are a result of wear from routine use, 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 Key10812726
MDR Text Key215529178
Report Number3004608878-2020-00648
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 10/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2020
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 Received11/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-