MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 40 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 482317540

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/04/2022

Event Type  malfunction  

Manufacturer Narrative

Device remains implanted.

Event Description

It was reported that the tulip of a xia 3 polyaxial screw broke off from the screw shaft post-operatively.Revision surgery has not been scheduled or performed at this time.

Event Description

It was reported that the tulip of a xia 3 polyaxial screw broke off from the screw shaft post-operatively.Revision surgery has not been scheduled or performed at this time.

Manufacturer Narrative

The device remains implanted and therefore unavailable for evaluation.Device history records could not be reviewed as a valid lot number was not provided and could not be obtained.Complaint history records were reviewed for this catalog number and no adverse trends were identified.The event of tulip disengagement was confirmed via imaging provided by the reported physician.Limited information regarding the event was made available to stryker.Multiple attempts were made to obtain additional information, but no response was received.A definitive root cause cannot be established.If additional information is received or the device is returned for evaluation, the investigation will be reopened and updated.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 40 MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 14547556
• MDR Text Key: 293352452
• Report Number: 0009617544-2022-00058
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04546540562340
• UDI-Public: 04546540562340
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 482317540
• Device Catalogue Number: 482317540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/04/2022
• Initial Date FDA Received: 05/31/2022
• Supplement Dates Manufacturer Received: 07/27/2022
• Supplement Dates FDA Received: 08/23/2022
• 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
• Patient Sex: Female