MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA LP POLYAXIAL SCREW 5.5 X 45MM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Model Number 03821545

Device Problems Detachment Of Device Component (1104); Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 12/02/2017

Event Type  malfunction  

Event Description

It was reported that; patient was put in prone position.This was a regular operation sterilization spread towels, full clear surgical field exposure, conventional cone, open open device agent take nail, needle, the establishment of fluoroscopy location is good, choose screw implant, poor position after perspective.Surgeon removed the screw, found the screw detached and never recovered.

Manufacturer Narrative

No relevant manufacturing issues were identified, as all units met specifications.Excessive force was most likely applied to the implant, causing the tulip to disengage, causing the deformation seen on the implant.Possible cross threading of the screwdriver, difficult angle of the tulip head or inadequate preparation of the pathway are root causes for the user to apply excess force to remove the implant and cause the tulip to disengage.

Event Description

It was reported that; patient was put in prone position.This was a regular operation sterilization spread towels, full clear surgical field exposure, conventional cone, open device agent take nail, needle, the establishment of fluoroscopy location is good, choose screw implant, poor position after perspective.Surgeon removed the screw, found the screw detached and never recovered.

• Brand Name: XIA LP POLYAXIAL SCREW 5.5 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: margarita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 7199493
• MDR Text Key: 97901401
• Report Number: 3005525032-2018-00003
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 04546540149183
• UDI-Public: (01)04546540149183
• Combination Product (y/n): N
• Reporter Country Code: CN
• 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: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 03821545
• Device Catalogue Number: 03821545
• Device Lot Number: B72020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2017
• 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