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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA YORK, PA INC. ULTRA-COAT KERRISON MICRO 40D UP 8 4MM
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INTEGRA YORK, PA INC. ULTRA-COAT KERRISON MICRO 40D UP 8 4MM Back to Search Results
Catalog Number RB5864
Device Problem Device Fell (4014)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/06/2020
Event Type  malfunction  
Manufacturer Narrative
The device was not yet received by the manufacturer for evaluation.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 on (b)(6) 2020, the screw from the rb5864 ultra-coat kerrison micro 40d up 8 4mm fell out during a laminectomy procedure.There was no patient injury and no known delay in surgery was reported.The screw was retrieved and placed back in the kerrison.
 
Manufacturer Narrative
Udi#: (b)(4).Sample was received for evaluation.The reported complaint was confirmed as the screw was loose and could have fallen out due to normal wear.No manufacturing, workmanship, or material deficiency has been identified.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
ULTRA-COAT KERRISON MICRO 40D UP 8 4MM
Type of Device
ULTRA-COAT
Manufacturer (Section D)
INTEGRA YORK, PA INC.
589 davies drive
589 davies drive
york PA 17402
MDR Report Key10280550
MDR Text Key202728817
Report Number2523190-2020-00055
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
PMA/PMN Number
K150428
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 05/05/2020
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? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberRB5864
Device Lot Number1001801803
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/12/2020
Date Manufacturer Received06/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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