MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.0 X 45 MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number 482317045

Device Problems Mechanical Problem (1384); Malposition of Device (2616)

Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)

Event Date 10/27/2015

Event Type  Injury  

Event Description

It was reported the doctor performed an l2-l5 posterior spinal fusion with an l4-l5 tlif on (b)(6) 2015.The patient who received the surgery came to his office complaining of low back pain on his left side.Upon analysis of x-rays, it was determined the left l5 screw had moved in the pedicle and was no longer engaged with the rod.On (b)(6) 2015, a revision surgery was performed on the patient to remove the screw that was causing the patient pain and to implant a new rod.

Manufacturer Narrative

Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: wear is visible at the base of the tulip at the beginning of the shank.The depression on the tulip head is visual confirmation of tightening force application.Furthermore scratching to the tulip exterior was observed with no functional consequence.Conclusion: the root cause of this event is likely multifactorial in nature.It should be noted that too much resistance force applied can cause screws to pull out post op due to decreased purchase.

Event Description

It was reported the doctor performed an l2-l5 posterior spinal fusion with an l4-l5 tlif on (b)(6) 2015.The patient who received the surgery came to his office complaining of low back pain on his left side.Upon analysis of x-rays, it was determined the left l5 screw had moved in the pedicle and was no longer engaged with the rod.On (b)(6) 2015, a revision surgery was performed on the patient to remove the screw that was causing the patient pain and to implant a new rod.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.0 X 45 MM
• Type of Device: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• Manufacturer (Section G): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• Manufacturer Contact: linford leitch ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5243448
• MDR Text Key: 31935610
• Report Number: 3005525032-2015-00135
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 482317045
• Device Lot Number: 60832
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/28/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/13/2015
• 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