MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW DIA 4.5 X 35 MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number 482314535

Device Problems Device Dislodged or Dislocated (2923); No Apparent Adverse Event (3189)

Patient Problems Test Result (2695); Not Applicable (3189)

Event Date 04/07/2015

Event Type  malfunction  

Event Description

It was reported that five days post op an x-ray was made to check the patient.A dislodgment of the road on three screws on the right side was noticed.

Manufacturer Narrative

Method: visual inspection; functional inspection.Conclusion: no issue was found with this xia 3 titanium polyaxial screw as it was determined to be a concomitant.

Event Description

It was reported that five days post op an x-ray was made to check the patient.A dislodgment of the road on three screws on the right side was noticed.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 4.5 X 35 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: 4740800
• MDR Text Key: 5774224
• Report Number: 3005525032-2015-00047
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K113666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/07/2015

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: 482314535
• Device Lot Number: A84706
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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