MAUDE Adverse Event Report: ORTHOFIX SRL XCALIBER; XCALIBER ANKLE KIT

Model Number 99-91647

Device Problem Crack (1135)

Patient Problem No Code Available (3191)

Event Date 04/27/2018

Event Type  malfunction  

Event Description

Information provided states that during a revision to tighten a screw that was loosening on the fixator, it was noticed that the fixator was cracked.An additional surgery was performed to replace the x-caliber fixator with a different system.

• Brand Name: XCALIBER
• Type of Device: XCALIBER ANKLE KIT
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni 9; bussolengo, verona 37012 ; IT 37012
• MDR Report Key: 7555198
• MDR Text Key: 109749791
• Report Number: 2183449-2018-00014
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 99-91647
• Device Lot Number: V1341747
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/30/2018
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 51 YR