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

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VLP MINI-MOD 1.5MM T PL 2H HD 8H SFT PLATE, 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
 

SMITH & NEPHEW, INC. VLP MINI-MOD 1.5MM T PL 2H HD 8H SFT PLATE, FIXATION, BONE Back to Search Results
Model Number 74411506
Device Problem Difficult to Insert (1316)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/08/2020
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that the vlp minimod 1. 5 titanium plate and screws were used to treat a fracture of the fifth phalanx. During the procedure the second hole and the third hole of the titanium plate could not be locked with the locking screw, and a new titanium plate and new screws were inserted into the patient. It was necessary to unscrew already placed screws in order to switch to the other plate and drill unplanned bone holes in order to put the new plate. Intraoperative fracture reset satisfactorily.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVLP MINI-MOD 1.5MM T PL 2H HD 8H SFT
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key11090924
MDR Text Key224245113
Report Number1020279-2020-07938
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/15/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/29/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number74411506
Device Catalogue Number74441516
Device LOT Number19KM05512
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/10/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-