MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM R T R PARALLEL CONNECTOR ANGLED - SIDE LOADING; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number 48235010

Device Problems Use of Device Problem (1670); Detachment of Device or Device Component (2907)

Patient Problem Pain (1994)

Event Date 08/13/2019

Event Type  Injury  

Event Description

A physician reported that a patient experienced pain post-operatively.Imaging indicated that a rod had detached from the xia 3 titanium parallel side-loading connector.The patient underwent revision surgery.

Manufacturer Narrative

Correction to concomitant medical products and device manufacture date; update from no to return and manufacturing date was added.Visual inspection: no damage was found on the threading.Slight deformation was found on the bottom of the rod to rod connectors where the rod seats, most likely from tightening the rod down.Functional inspection: blockers were able to be threaded down into the connector with no issues.A review of the device history and complaint history records showed no relevant manufacturing issues were identified as all units met stryker specifications and no similar complaints were identified.From the xia instructions for use: because different manufacturers employ different materials, varying tolerances and manufacturing specifications, and differing design parameters, components of the system should not be used in conjunction with components from any other manufacturer¿s spinal system.Any such use will negate the responsibility of stryker spine for the performance of the resulting mixed component implant.As the connectors were used with another company's rods, stryker spine is not responsible for the performance of the construct.No further action is required.

Event Description

A physician reported that a patient experienced pain post-operatively.Imaging indicated that a rod had detached from the xia 3 titanium parallel side-loading connector.The patient underwent revision surgery.

• Brand Name: XIA 3 TITANIUM R T R PARALLEL CONNECTOR ANGLED - SIDE LOADING
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9000861
• MDR Text Key: 157767818
• Report Number: 3005525032-2019-00076
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04546540602404
• UDI-Public: 04546540602404
• Combination Product (y/n): N
• PMA/PMN Number: K142381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 48235010
• Device Lot Number: B82654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Date Manufacturer Received: 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 70