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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD SWIVEL ADAPTOR; SKULL PINS
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INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD SWIVEL ADAPTOR; SKULL PINS Back to Search Results
Catalog Number A1018
Device Problem Fitting Problem (2183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
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 a1018 mayfield swivel adaptor doesn't tighten fully to skull clamp.There was no known patient injury or surgery delay.
 
Event Description
N/a.
 
Manufacturer Narrative
(b)(4).The device was returned for evaluation.The dhr documentation showed no abnormalities related to the reported failure.The reported complaint was confirmed via inspection of the unit.Unit received with the torque screw threads bent so the adaptor could not tighten properly.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 SWIVEL ADAPTOR
Type of Device
SKULL PINS
Manufacturer (Section D)
INTEGRA LIFESCIENCES CORPORATION OH/USA
4900 charlemar drive
4900 charlemar drive
cincinnati OH 45227
MDR Report Key10543646
MDR Text Key207325002
Report Number3004608878-2020-00526
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,user f
Type of Report Initial,Followup
Report Date 08/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberA1018
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/24/2020
Date Manufacturer Received09/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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