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 MODIFIED SKULL CLAMP; N/A
  • 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 MODIFIED SKULL CLAMP; N/A Back to Search Results
Catalog Number A1059
Device Problem Insufficient Information (3190)
Patient Problem Injury (2348)
Event Type  Injury  
Manufacturer Narrative
The device was not yet returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.
 
Event Description
A customer reported that the a1059 mayfield modified skull clamp was involved in an unspecified patient injury.There was no report of surgical delay.The date of the incident is unknown.Additional information has been requested.
 
Event Description
N/a.
 
Manufacturer Narrative
Additional information: d10, g4, g7, h2, h3, h6, h10.Unique device identifier (udi): (b)(4).The device was returned for evaluation.Investigation showed that the lock had rotational movement when in the unlocked position, no other issues were observed, and the unit passed all specific functional testing requirements.Device was manufactured in 2008.The reported complaint was not confirmed.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 MODIFIED SKULL CLAMP
Type of Device
N/A
Manufacturer (Section D)
INTEGRA LIFESCIENCES CORPORATION OH/USA
4900 charlemar drive
4900 charlemar drive
cincinnati OH 45227
MDR Report Key10280493
MDR Text Key202714595
Report Number3004608878-2020-00249
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 04/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberA1059
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/26/2020
Date Manufacturer Received06/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-