MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 VITALIUM ROD WITH HEX 6.0MM X 600MM; SPINAL INTERLAMINAL FIXATION ORTHOSIS.

Model Number	48232601
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Injury (2348); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	05/30/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; primary surgery was performed on (b)(6) 2014, and 1st revision surgery was performed on (b)(6) 2014.It was reported as (b)(6).The rod breakage due to the nonunion was found (right t9/10, left t10/11), the 2nd revision surgery was performed on (b)(6) 2017.During the surgery, the set screws of the connector snapped off.The surgeon exchanged with the new screws.
Additional Manufacturer Narrative
Method: risk assessment; results: visual, dimensional and functional analysis could not be performed as the device was not returned.The rep reported that the rod breakage due to the nonunion was found.Conclusion: the most likely root cause is delayed healing/ non fusion.
Event or Problem Description
It was reported that; primary surgery was performed on (b)(6) 2014, and 1st revision surgery was performed on (b)(6) 2014.It was reported as (b)(4).The rod breakage due to the nonunion was found (right t9/10, left t10/11), the 2nd revision surgery was performed on (b)(6) 2017.During the surgery, the set screws of the connector snapped off.The surgeon excanged with the new screws.

• Brand Name: XIA 3 VITALIUM ROD WITH HEX 6.0MM X 600MM
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS.
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 6671818
• Report Number: 3005525032-2017-00075
• Device Sequence Number: 72117
• Product Code: KWP
• UDI-Device Identifier: 04546540608642
• UDI-Public: (01)04546540608642
• Combination Product (Y/N): N
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2017

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 Model Number: 48232601
• Device Catalogue Number: 48232601
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/30/2017
• Supplement Date Received by Manufacturer: 05/30/2017
• Initial Report FDA Received Date: 06/27/2017
• Supplement Report FDA Received Date: 09/15/2017
• 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