• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC PRECISION IO SCAN ADAPTER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

IMPLANT DIRECT SYBRON MANUFACTURING LLC PRECISION IO SCAN ADAPTER Back to Search Results
Catalog Number 6050-09PT
Device Problem Inaccurate Information (4051)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/18/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Per internal complaint (b)(4), the flat scan of the scan adapter was found not aligned to the tri-lobe.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
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 Key7791700
MDR Text Key117432935
Report Number3001617766-2018-00197
Device Sequence Number1
Product Code NDP
UDI-Device Identifier10841307123958
UDI-Public10841307123958
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 Other
Remedial Action Recall
Type of Report Initial
Report Date 08/16/2018
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
Device Operator No Information
Device Expiration Date11/14/2022
Device Catalogue Number6050-09PT
Device Lot Number104511
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/18/2018
Initial Date FDA Received08/16/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/14/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-