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

MAUDE Adverse Event Report: DEPUY SPINE INC MIS SINGLE INNER SETSCW SCREW,FIXATION,BONE

  • 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
 

DEPUY SPINE INC MIS SINGLE INNER SETSCW SCREW,FIXATION,BONE Back to Search Results
Catalog Number 186715000
Device Problem Unintended Movement
Event Date 01/01/2019
Event Type  Injury  
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMIS SINGLE INNER SETSCW
Type of DeviceSCREW,FIXATION,BONE
Manufacturer (Section D)
DEPUY SPINE INC
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham , MA 02767
6103142063
MDR Report Key9580988
Report Number1526439-2020-00362
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 12/25/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/13/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number186715000
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/29/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/12/2020
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 01/13/2020 Patient Sequence Number: 1
-
-