MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA LP MONOAXIAL SCREW 6.5 X 40MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	03820640
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	01/20/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by that during aqua gym the metal side plate was broken.Also, the head of a screw was broken to mono axial screm with the same movement.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment.Results: the customer reported event was confirmed via a visual inspection of the device.Visual inspection confirmed the presence of beach marks, which are consistent with fatigue fracture.No relevant manufacturing issues were identified during record review for the corresponding lot.Conclusion: the most likely cause of the customer reported event is a fatigue of the device due to prolonged implantation.
Event or Problem Description
It was reported by that during aqua gym the metal side plate was broken.Also, the head of a screw was broken to mono axial screm with the same movement.

• Brand Name: XIA LP MONOAXIAL SCREW 6.5 X 40MM
• 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: 5439625
• Report Number: 3005525032-2016-00018
• Device Sequence Number: 16204897
• Product Code: NKB
• UDI-Device Identifier: 04546540148902
• UDI-Public: 04546540148902
• Combination Product (Y/N): N
• PMA/510(K) Number: K013823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2016

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: 03820640
• Device Lot Number: A71891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/04/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/16/2016
• Supplement Report FDA Received Date: 08/04/2016
• 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