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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD ULTRA BASE UNIT; BASE UNITS AND ADAPTERS
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INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD ULTRA BASE UNIT; BASE UNITS AND ADAPTERS Back to Search Results
Catalog Number A2101
Device Problem Fitting Problem (2183)
Patient Problem No Patient Involvement (2645)
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 3004608878-2020-00639.
 
Event Description
This is 2 of 2 reports.It was reported that the transitional member was not fitting.There was no patient involvement nor surgery delay.
 
Event Description
N/a.
 
Manufacturer Narrative
Udi: (b)(4).Device history record (dhr) - the dhr shows no abnormalities related to the reported failure.The reported complaint was confirmed from the evaluation of the returned mayfield base unit.The base handle was closed without 6in transitional installed and deformed hole.The observed condition is likely caused by improperly handling of the device.The definite root cause cannot be reliably determined.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 ULTRA BASE UNIT
Type of Device
BASE UNITS AND ADAPTERS
Manufacturer (Section D)
INTEGRA LIFESCIENCES CORPORATION OH/USA
4900 charlemar drive
4900 charlemar drive
cincinnati OH 45227
MDR Report Key10746698
MDR Text Key213415890
Report Number3004608878-2020-00640
Device Sequence Number1
Product Code FWZ
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberA2101
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/14/2020
Date Manufacturer Received11/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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