MAUDE Adverse Event Report: STRYKER SPINE-US XIA TITANIUM 4.5 EXTENDED CONNECTOR LARGE; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	48135104
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	09/30/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the extended connector has broken inside the patient.The patient was complaining of the pain and the event was conformed via x-ray examination.The patient underwent revision surgery.
Additional Manufacturer Narrative
Method: x-ray image review, visual inspection, material analysis, product history review, complaint history review, nc/capa history review, result: the reported event was confirmed via visual inspection and review of the x rays.The device was returned fractured in 2 pieces, one end of the connector was completely separated from the main shaft.The base material composition of the connector was measured by energy-dispersive spectroscopy (eds).The eds spectrum shows that material is confirming.No relevant manufacturing issues were identified for the reported lot # as all released units met specifications.No similar complaints were identified for this lot number.Review of the x-rays showed that the construct was fixed at upper thoracic levels and at lumbar levels, with no additional fixation in between.The existing curve and the placement of the devices allowed for a large bending moment to exist within the non-fixed region, which can eventually cause a fatigue breakage of connector.Previous material analysis of a similar complaint device found that the connector resulted in a fatigue fracture.Corrective action preventative action (capa) was opened on to house the investigation which resulted in design change.The goal of this capa was to create new connectors that can be used in growing rod (pediatric applications), with larger cross-sectional area.The change to the growth connector from the extended connector will eliminate the stress concentration area in addition to increasing the cross-sectional area to improve its mechanical strength characteristics for the future use of the product for the expanded indications (pediatric growing rod applications).According to the indications for use from surgical technique: the device is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (ddd), spondylolisthesis, trauma, tumor, pseudarthrosis, failed previous fusion.The root cause of the reported event based on the capa: the extended connector large is designed to be thin in the middle and larger on the ends.The relative difference in size between the middle of the connector and the ends serves as a stress concentration.If the extended connector is subject to growing rod conditions (pediatric application), the stress concentration combined with the higher expected loads of a growing rod could create a potential fracture location.Conclusion: the most likely root cause for the reported event is user error since it was used in the 9 years old patient.
Event or Problem Description
It was reported that the extended connector has broken inside the patient.The patient was complaining of the pain and the event was conformed via x-ray examination.The patient underwent revision surgery.

• Brand Name: XIA TITANIUM 4.5 EXTENDED CONNECTOR LARGE
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8011511
• Report Number: 0009617544-2018-00250
• Device Sequence Number: 1262435
• Product Code: KWQ
• UDI-Device Identifier: 04546540449597
• UDI-Public: 04546540449597
• Combination Product (Y/N): N
• Initial Reporter Country: IR
• PMA/510(K) Number: K121342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2019

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: No Information
• Device Catalogue Number: 48135104
• Device Lot Number: 142209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Initial Date Received by Manufacturer: 10/06/2018
• Supplement Date Received by Manufacturer: 12/26/2018
• Initial Report FDA Received Date: 10/28/2018
• Supplement Report FDA Received Date: 01/09/2019
• 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: 9 YR
• Patient Weight: 25