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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA STANDARD INFINITY SKULL CLAMP; N/A
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INTEGRA LIFESCIENCES CORPORATION OH/USA STANDARD INFINITY SKULL CLAMP; N/A Back to Search Results
Catalog Number A1114A
Device Problem Loose or Intermittent Connection (1371)
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 lock on the handle of the mayfield infinity skull clamp (a1114a) was very loose.It is unknown if there was patient involvement or if the device failure led to patient injury or surgical delay.
 
Manufacturer Narrative
The mayfield infinity skull clamp was returned for evaluation.The reported complaint was confirmed via inspection of the item.The lock had movement and required replacement of worn internal parts.Unit is beyond integra¿s 7 years recommended life cycle (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
STANDARD INFINITY 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 Key11219372
MDR Text Key228844039
Report Number3004608878-2021-00023
Device Sequence Number1
Product Code HBL
Combination Product (y/n)N
PMA/PMN Number
K051440
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 03/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberA1114A
Device Lot Number124
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/02/2021
Date Manufacturer Received02/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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