MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA LP MONOAXIAL SCREW 6.5 X 45MM; IMPLANT-SCREW

Catalog Number 03820645

Device Problems Break (1069); Malposition of Device (2616)

Patient Problem No Information (3190)

Event Date 04/10/2014

Event Type  Injury  

Event Description

It was reported that x-rays has been noticed that the screw was broken.Surgeon opinion is that the screw was not exactly in the pedicle.

Manufacturer Narrative

Method: visual inspection; device history review; complaint history review; risk assessment; results: the device was inspected and confirmed to be fractured.The appearance of the beachmarks and their orientation are consistent with bending fatigue fracture.A material analysis performed determined the breakage to be due to fatigue breakage.Lastly, no manufacturing issues were identified during manufacturing record review.Conclusion: the length of implantation (approximately 1 year) suggests that the most likely cause of the reported event is a fatigue fracture.

Event Description

It was reported that x-rays has been noticed that the screw was broken.Surgeon opinion is that the screw was not exactly in the pedicle.

• Brand Name: XIA LP MONOAXIAL SCREW 6.5 X 45MM
• Type of Device: IMPLANT-SCREW
• 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: 3871109
• MDR Text Key: 4461289
• Report Number: 0009617544-2014-00265
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: IR
• PMA/PMN Number: K013823
• 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: 05/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03820645
• Device Lot Number: TBD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/20/2014
• Initial Date FDA Received: 06/13/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2011
• 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