MAUDE Adverse Event Report: TORNIER INC. FUTURA CSI SUBTALAR IMPLANT DIAMETER 11; SUBTALAR PEG IMPLANT

Catalog Number CSI-11

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 06/25/2017

Event Type  Injury  

Event Description

It was reported that the screw became loose at 3 days post-op.

• Brand Name: FUTURA CSI SUBTALAR IMPLANT DIAMETER 11
• Type of Device: SUBTALAR PEG IMPLANT
• Manufacturer (Section D): TORNIER INC.; 10801 nesbit avenue south; bloomington MN 55437
• Manufacturer Contact: dustin smith ; 10801 nesbit ave south; bloomington, MN 55437 ; 9529217121
• MDR Report Key: 7078602
• MDR Text Key: 93586796
• Report Number: 3004983210-2017-00029
• Device Sequence Number: 1
• Product Code: MJW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K033046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: CSI-11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2017
• 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