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
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/13/2019
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9000861
• Report Number: 3005525032-2019-00076
• Device Sequence Number: 2657155
• Product Code: NKB
• UDI-Device Identifier: 04546540602404
• UDI-Public: 04546540602404
• Combination Product (Y/N): N
• PMA/510(K) Number: K142381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 10/17/2019
• Initial Report FDA Received Date: 09/12/2019
• Supplement Report FDA Received Date: 11/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Weight: 70