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

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).

• 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 Key: 18207753
• MDR Text Key: 328958036
• Report Number: 0001649390-2023-00327
• Device Sequence Number: 1
• Product Code: KWD
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• 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

• Date FDA Received: 11/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_WTB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2023
• 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 Number: 1
• Patient Outcome(s): Required Intervention