MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA LP POLYAXIAL SCREW 7.5 X 45MM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Catalog Number 03821745

Device Problems Device Slipped (1584); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/08/2015

Event Type  malfunction  

Event Description

It was reported regarding five screws total, that the tulip heads popped off during a revision surgery.The original surgery was in (b)(6) 2014.Larger diameter screws has to be used which the surgeon didn't want to do originally.

Manufacturer Narrative

(b)(4).Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment.Results: the reported disengagement was confirmed through inspection of the device.The inspection revealed deformation on the screw tulip around the edge of the bone screw hole, which suggests that the issue occurred during persuasion as there was no deformation on the bone screw head.Conclusion: however, multiple factors can also affect this, including surgeon technique and the condition of the existing construct.Due to the multifactorial nature of the event, the root cause cannot be determined conclusively.

Event Description

It was reported regarding five screws total, that the tulip heads popped off during a revision surgery.The original surgery was in (b)(6) 2014.Larger diameter screws has to be used which the surgeon didn't want to do originally.

• Brand Name: XIA LP POLYAXIAL SCREW 7.5 X 45MM
• Type of Device: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• 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: 4740803
• MDR Text Key: 19613844
• Report Number: 3005525032-2015-00049
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060361
• 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: 04/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03821745
• Device Lot Number: B25343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2012
• 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