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

MAUDE Adverse Event Report: OSTEOMED HAND PLATING SYSTEM 2.0MM 12-HOLE STRAIGHT PLATE, LOCKING

  • 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
 

OSTEOMED HAND PLATING SYSTEM 2.0MM 12-HOLE STRAIGHT PLATE, LOCKING Back to Search Results
Catalog Number 333-2002
Device Problem Break (1069)
Patient Problems Bone Fracture(s) (1870); No Information (3190); Missing Value Reason (3192)
Event Type  Malfunction  
Event Description

On (b)(6) 2018, osteomed was notified of an incident with the 2. 0mm 6 hole straight plate, locking (p/n 333-2001). Per the distributor, there was a fracture of 2 metacarpal of the left hand due to gunshot wound with partial loss of the metacarpal that required iliac crest grafting. This was on the patient's right hand. After 6 months of surgery, the plate broke in one of its holes.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHAND PLATING SYSTEM
Type of Device2.0MM 12-HOLE STRAIGHT PLATE, LOCKING
Manufacturer (Section D)
OSTEOMED
3885 arapaho road
addison TX 75001
Manufacturer (Section G)
OSTEOMED
3885 arapaho road
addison TX 75001
Manufacturer Contact
latoia phillips
3885 arapaho road
addison, TX 75001
MDR Report Key7311552
MDR Text Key101702119
Report Number2027754-2018-00004
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeCO
PMA/PMN NumberK090522
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/02/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/02/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device Catalogue Number333-2002
Device LOT Number1047211
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/09/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/12/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/05/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 03/02/2018 Patient Sequence Number: 1
-
-