MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 45 MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number 482317545

Device Problems Break (1069); Detachment Of Device Component (1104); Mechanical Problem (1384); Device Slipped (1584)

Patient Problems Injury (2348); No Information (3190)

Event Date 09/12/2016

Event Type  Injury  

Event Description

It was reported that; the screw tulip head popped off of left l4 screw 3 days post op.Original surgery was (b)(6).L3-l5 posterior fusion.L4 screw was removed and not replaced.The broken screw has been sent to pathology and will be released sometime within the next 2 weeks.At that point i will ship back to stryker.

Manufacturer Narrative

Method: device history review; complaint history review; risk assessment; results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Visual, dimensional and functional analysis could not be performed as the device was not returned.Conclusion: the definitive root cause of the event cannot be determined with the given information.

Event Description

It was reported that; the screw tulip head popped off of left l4 screw 3 days post op.Original surgery was (b)(6).L3-l5 posterior fusion.L4 screw was removed and not replaced.The broken screw has been sent to pathology and will be released sometime within the next 2 weeks.At that point i will ship back to stryker.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 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: christa marrow ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 6004504
• MDR Text Key: 56764779
• Report Number: 3005525032-2016-00124
• Device Sequence Number: 1
• Product Code: MNI
• UDI-Device Identifier: 04546540562357
• UDI-Public: (01)04546540562357
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/24/2017

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: No Information
• Device Catalogue Number: 482317545
• Device Lot Number: B13101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/13/2016
• Initial Date FDA Received: 10/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2011
• 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): Required Intervention