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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD INFINITY XR2 SKULL CLAMP
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INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD INFINITY XR2 SKULL CLAMP Back to Search Results
Catalog Number A2114
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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 the mayfield infinity skull clamp (product id a2114) was broken.It is unknown if there was patient involvement or if the device failure led to patient injury or surgical delay.
 
Manufacturer Narrative
Udi: (b)(4).The reported complaint was confirmed from the evaluation of the returned mayfield infinity skull clamp.Unit received without pedi rocker arm or suit case.Evaluation showed that the left and right pawls of the device are worn.The unit needs repair, and replacement of worn parts.General maintenance and cleaning required.This device exceeds its expected life of 7 years (manufactured in 2012).No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.
 
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Brand Name
MAYFIELD INFINITY XR2 SKULL CLAMP
Type of Device
MAYFIELD
Manufacturer (Section D)
INTEGRA LIFESCIENCES CORPORATION OH/USA
4900 charlemar drive
4900 charlemar drive
cincinnati OH 45227
MDR Report Key10954020
MDR Text Key220237741
Report Number3004608878-2020-00726
Device Sequence Number1
Product Code HBL
Combination Product (y/n)N
PMA/PMN Number
K130389
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 11/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberA2114
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/25/2020
Initial Date Manufacturer Received 11/10/2020
Initial Date FDA Received12/05/2020
Supplement Dates Manufacturer Received12/29/2020
Supplement Dates FDA Received01/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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