MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA II VITALIUM ROD 6.0 MM X 600 MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	03822601
Medical Device Problem Code	Disassembly (1168)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	10/04/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; rods slipped through the tulip heads of the pedicel screws.
Additional Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, risk assessment.Result: inspection of the returned device did not reveal any visual non-conformances.No relevant manufacturing issues were identified as all units met stryker specifications.Conclusion: the most likely cause of the customer reported event is the high activity level of the patient with the over-tightening likely contributing to the event.
Event or Problem Description
It was reported that; rods slipped through the tulip heads of the pedicel screws.

• Brand Name: XIA II VITALIUM ROD 6.0 MM X 600 MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 6067939
• Report Number: 0009617544-2016-00434
• Device Sequence Number: 19048438
• Product Code: NKB
• UDI-Device Identifier: 04546540539656
• UDI-Public: (01)04546540539656
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2017

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: 03822601
• Device Lot Number: J48
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/04/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2016
• Supplement Report FDA Received Date: 01/06/2017
• 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 Age: 18 YR