MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM LONG OFFSET CONNECTOR; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Catalog Number	48230133
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Perforation (2001); Injury (2348)
Date of Event	08/25/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; on (b)(6) 2016, surgery was performed for spinal deformity due to parkinson's disease.T5 - iliac were fixed and the rod connectors were used for iliac.After that, the rod connectors broke and the rod perforated the skin.The revision surgery was performed on (b)(6) 2016.Exchange and adding of iliac screw has done.The blocker which inserted the right iliac screw was loose.
Additional Manufacturer Narrative
Visual inspection; material analysis; device history review; complaint history review; risk assessment.The device was inspected and sent for a material analysis and it was confirmed that the connector experienced a fatigue fracture.The ifu states the following: the components cannot be expected to indefinitely withstand the activity level and loads of normal healthy bone.The most likely cause of the fracture is a fatigue of the device due to loads produced by the body on the implant.
Event or Problem Description
It was reported that; on (b)(6) 2016, surgery was performed for spinal deformity due to parkinson's disease.T5 - iliac were fixed and the rod connectors were used for iliac.After that, the rod connectors broke and the rod perforated the skin.The revision surgery was performed on (b)(6) 2016.Exchange and adding of iliac screw has done.The blocker which inserted the right iliac screw was loose.

• Brand Name: XIA 3 TITANIUM LONG OFFSET CONNECTOR
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 5957735
• Report Number: 3005525032-2016-00110
• Device Sequence Number: 10937351
• Product Code: KWQ
• UDI-Device Identifier: 04546540602282
• UDI-Public: (01)04546540602282
• Combination Product (Y/N): N
• PMA/510(K) Number: K083393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2016

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: 48230133
• Device Lot Number: B46252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/25/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/16/2016
• Supplement Report FDA Received Date: 11/29/2016
• 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: 54 YR
• Patient Weight: 53