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

Catalog Number 03822601

Device Problems Disassembly (1168); Device Slipped (1584)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 10/04/2016

Event Type  Injury  

Event Description

It was reported that; rods slipped through the tulip heads of the pedicel screws.

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 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
• Type of Device: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• Manufacturer (Section G): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• Manufacturer Contact: rakshya bista ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 6067939
• MDR Text Key: 58815677
• Report Number: 0009617544-2016-00434
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04546540539656
• UDI-Public: (01)04546540539656
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2016
• Initial Date FDA Received: 10/31/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 18 YR