MAUDE Adverse Event Report: ORTHOFIX INC SPINA FIXATION SYSTEM; 4.5MM X 50MM MULTI- AXIAL BONE SCREW

Model Number 56-3850

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2016

Event Type  malfunction  

Event Description

Information provided states that during a surteron the central part of the screw came loose.Pt was being treated for arthorodesis low back.No adverse events to patient.Patient has made good progress.

Event Description

Information provided states that during a surgery the central part of the screw came loose.Pt was being treated for arthorodesis low back.No adverse events to patient.Patient has made good progress.

• Brand Name: SPINA FIXATION SYSTEM
• Type of Device: 4.5MM X 50MM MULTI- AXIAL BONE SCREW
• Manufacturer (Section D): ORTHOFIX INC; 3451 plano parkway; lewisville TX 75056
• Manufacturer (Section G): ORTHOFIX INC; 3451 plano parkway; lewisville TX 75056
• Manufacturer Contact: yolanda thompson ; 3451 plano parkway; lewisville, TX 75056 ; 2149372291
• MDR Report Key: 5959146
• MDR Text Key: 55337764
• Report Number: 2183449-2016-00019
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K013558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 56-3850
• Device Lot Number: A01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2011
• 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): Other
• Patient Age: 76 YR