MAUDE Adverse Event Report: EXACTECH, INC SILVERBOLT CAP & SET SCREW; CAP AND SET SCREW

Catalog Number 201-0002

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Engineering evaluation noted that the revision reported was likely the result of either not fully tightening the set screw at the time of implantation or the set screw becoming loose while implanted, which failed to secure the polyaxial motion of the screw, and allowed the rod to move within the tulip.

Event Description

Revision surgery with silverbolt implants.

• Brand Name: SILVERBOLT CAP & SET SCREW
• Type of Device: CAP AND SET SCREW
• Manufacturer (Section D): EXACTECH, INC; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: graham cuthbert ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 6343277
• MDR Text Key: 67817993
• Report Number: 1038671-2017-00091
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• 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: 10/04/2016,02/20/2017

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: Physician
• Device Catalogue Number: 201-0002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2016
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Report to Manufacturer: 10/04/2016
• Initial Date Manufacturer Received: 10/04/2016
• Initial Date FDA Received: 02/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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