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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC REPLANT® PRECISION IO SCAN ADAPTER
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IMPLANT DIRECT SYBRON MANUFACTURING LLC REPLANT® PRECISION IO SCAN ADAPTER Back to Search Results
Catalog Number 6035-09PT
Medical Device Problem Code Nonstandard Device (1420)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/17/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Hhe replant scan adapter (b)(4).
 
Event or Problem Description
Per complaint (b)(4), the scan body sent to the lab was assembled incorrectly.The plastic portion of the scan body was incorrectly attached to the titanium base portion of it.The flat side of it is not where it should be.So, when it is scanned, it does not line up.
 
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Brand Name
REPLANT® PRECISION IO SCAN ADAPTER
Common Device Name
SCAN ADAPTER
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key7787685
Report Number3001617766-2018-00192
Device Sequence Number1939237
Product Code NDP
UDI-Device Identifier10841307123934
UDI-Public10841307123934
Combination Product (Y/N)N
Initial Reporter StateNE
Initial Reporter CountryUS
PMA/510(K) Number
872.398
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Remedial Action Recall
Type of Report Initial
Report Date (Section B) 08/15/2018
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 Date11/14/2022
Device Catalogue Number6035-09PT
Device Lot Number104539
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/01/2018
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/16/2018
Initial Report FDA Received Date08/15/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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