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

MAUDE Adverse Event Report: TORNIER INC UNKNOWN FUTURA¿ CONICAL SUBTALAR IMPLANT; PROSTHESIS, TOE, HEMI-, PHALANGEAL

  • 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
 

TORNIER INC UNKNOWN FUTURA¿ CONICAL SUBTALAR IMPLANT; PROSTHESIS, TOE, HEMI-, PHALANGEAL Back to Search Results
Catalog Number UNK_WTB
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Implant Pain (4561)
Event Date 10/30/2023
Event Type  Injury  
Manufacturer Narrative
The alleged event could not be confirmed, since no additional information was received from the author or the article.More detailed information about the patient medical history, the event circumstances, and medical reports must be available to determine the root cause.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.H3 other text : device not available.
 
Event Description
It was reported that a retrospective data collection of the radiographic clinical observational study on patients treated for flat foot with the futura¿ conical subtalar implant system (csi) was conducted to collect safety and efficacy/performance of the futura¿ conical subtalar implant system (csi).It was found that a patient had pain at the sinus tarsi (solved with screw removal).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNKNOWN FUTURA¿ CONICAL SUBTALAR IMPLANT
Type of Device
PROSTHESIS, TOE, HEMI-, PHALANGEAL
Manufacturer (Section D)
TORNIER INC
10801 nesbitt avenue s
bloomington MN 55437
Manufacturer (Section G)
TORNIER INC
10801 nesbitt avenue s
bloomington MN 55437
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key18207758
MDR Text Key328958155
Report Number0001649390-2023-00332
Device Sequence Number1
Product Code KWD
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Study
Reporter Occupation Physician
Type of Report Initial
Report Date 11/26/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Catalogue NumberUNK_WTB
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/30/2023
Initial Date FDA Received11/26/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-