MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 45 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM.

Model Number 482316545

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 08/22/2017

Event Type  malfunction  

Event Description

It was reported that the patient had been fused from l3-s1.As they were taking the instrumentation out of patient, screw was already broken.No harm was done to the patient and left the bottom half of the screw in the patient.

Manufacturer Narrative

No manufacturing defects were found.Visual inspection showed the screw was returned with the bottom portion of the threaded body fractured off and missing from the rest of the screw.The definitive root cause of the event cannot be determined with the given information.

Event Description

It was reported that the patient had been fused from l3-s1.As they were taking the instrumentation out of patient, screw was already broken.No harm was done to the patient and left the bottom half of the screw in the patient.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 45 MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW 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: 6876218
• MDR Text Key: 87621702
• Report Number: 3005525032-2017-00092
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 04546540562241
• UDI-Public: (01)04546540562241
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 482316545
• Device Catalogue Number: 482316545
• Device Lot Number: B50795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/05/2015
• 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