MAUDE Adverse Event Report: ORTHOFIX INC. PHOENIX MIS SPINAL FIXATION SYSTEM; SET SCREW (X2)

Model Number 44-2001

Device Problem Detachment Of Device Component (1104)

Patient Problem Pain (1994)

Event Date 06/11/2015

Event Type  malfunction  

Event Description

Based on the information provided, on (b)(6) 2015, the patient went to the emergency room with back and buttocks pain.It was discovered that the phoenix set screws came off of the right l4 and l5 screws of the construct.

• Brand Name: PHOENIX MIS SPINAL FIXATION SYSTEM
• Type of Device: SET SCREW (X2)
• Manufacturer (Section D): ORTHOFIX INC.; lewisville TX
• 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: 4926159
• MDR Text Key: 22460542
• Report Number: 3008524126-2015-00014
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122901
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Not Applicable
• Report Date: 07/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 44-2001
• Device Lot Number: S130, S131
• Other Device ID Number: 18257200009695
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/29/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• 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: 43 YR