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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; SCAN ADAPTOR
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IMPLANT DIRECT SYBRON MANUFACTURING LLC INTERACTIVE PRECISION IO SCAN ADAPTER; SCAN ADAPTOR Back to Search Results
Catalog Number 6534-09PT
Medical Device Problem Code Component Misassembled (4004)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 05/23/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Inspection confirmed product is out of specification.The potential cause is due to incorrect manufacturing.According to the risk management report, the severity of harm is serious.Complaint will be escalated for further investigation.
 
Event or Problem Description
Per complaint (b)(4), the peek part of the multi-use scan adaptor was loose on the titanium base.
 
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Brand Name
INTERACTIVE PRECISION IO SCAN ADAPTER
Common Device Name
SCAN ADAPTOR
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key8003168
Report Number3001617766-2018-00279
Device Sequence Number11134909
Product Code NDP
UDI-Device Identifier10841307123477
UDI-Public10841307123477
Combination Product (Y/N)N
Initial Reporter CountryNL
PMA/510(K) Number
872.3980
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Non-Healthcare Professional
Remedial Action Inspection
Type of Report Initial
Report Date (Section B) 10/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date11/08/2022
Device Catalogue Number6534-09PT
Device Lot Number104479
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/31/2018
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/22/2018
Initial Report FDA Received Date10/24/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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