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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING, LLC INTERACTIVE PRECISION IO SCAN ADAPTER
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IMPLANT DIRECT SYBRON MANUFACTURING, LLC INTERACTIVE PRECISION IO SCAN ADAPTER Back to Search Results
Catalog Number 6530-09PT
Device Problems Mechanical Problem (1384); Component Missing (2306); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
Internal complaint- claims (b)(4) were issued for part number 6534-09pt.The "invesitgation" expanded to part number 6530-09pt.Inspection order and it was found to have missing "featurs" and outside of diameter.Lot check determined the issued machined part number 6530-81pn-m, lot number 100780, was used in four different finished goods lot numbers, 104151, 106478, 114914 and 124072.There is no remaining inventory for all 4 lots.
 
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Brand Name
INTERACTIVE PRECISION IO SCAN ADAPTER
Type of Device
SCAN ADAPTER
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING, LLC
3050 east hillcrest drive.
thousand oaks CA 91362
Manufacturer Contact
adrienne stott
3050 east hillcrest drive.
thousand oaks, CA 91362
8184443300
MDR Report Key8143254
MDR Text Key129667680
Report Number3001617766-2018-00363
Device Sequence Number1
Product Code NDP
UDI-Device Identifier10841307123460
UDI-Public10841307123460
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
872.398
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number6530-09PT
Device Lot Number104151, 106478, 114914, 124072
Was Device Available for Evaluation? No
Date Manufacturer Received11/07/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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