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

Catalog Number	48232601
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Fall (1848); Injury (2348)
Date of Event	01/15/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; patient fell and it was noticed that the rod broke.Revision surgery (b)(6) 2017.Patient fused.
Additional Manufacturer Narrative
Lot# j4p.Method: visual inspection; device history review; complaint history review; risk assessment; results: no relevant manufacturing issues were identified as all units met specifications.Visual inspection confirmed the rod fractured completely.Conclusion: the possible root cause of the reported event is patient fall.
Event or Problem Description
It was reported that; patient fell and it was noticed that the rod broke.Revision surgery (b)(6) 2017.Patient fused.

• 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: 6425576
• Report Number: 3005525032-2017-00041
• Device Sequence Number: 18841656
• Product Code: KWP
• UDI-Device Identifier: 04546540608642
• UDI-Public: (01)04546540608642
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2017

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 Catalogue Number: 48232601
• Device Lot Number: J4P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/15/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/22/2017
• Supplement Report FDA Received Date: 05/24/2017
• 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
• Patient Weight: 159