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

MAUDE Adverse Event Report: ORTHO DEVELOPMENT BONE FIXATION SCREW

  • 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
 

ORTHO DEVELOPMENT BONE FIXATION SCREW Back to Search Results
Model Number 189-2142
Device Problem Appropriate Term/Code Not Available
Event Date 02/13/2018
Event Type  Injury  
Manufacturer Narrative

Product is export only. No 510(k). The device history record was reviewed and showed the device was manufactured according to specification.

 
Event Description

After initial implantation surgery, the patient fell and reported subsequent pain. An x-ray on (b)(6) 2018 revealed one of the bone screws had backed out. The surgeon plans a revision but it has not yet occurred.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of DeviceBONE FIXATION SCREW
Manufacturer (Section D)
ORTHO DEVELOPMENT
12187 s. business park drive
draper UT 84020
Manufacturer (Section G)
ORTHO DEVELOPMENT
12187 s. business park drive
draper UT 84020
Manufacturer Contact
drew weaver
12187 s. business park drive
draper , UT 84020
8015539991
MDR Report Key7511773
Report Number1722511-2018-00016
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN
Reporter Occupation
Type of Report Initial
Report Date 04/17/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/14/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number189-2142
Device LOT NumberA178787
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/17/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/05/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-